Chronic PainPhase 1NCT05329454
To Evaluate the Food Effect and the Absorption Profile of Ibuprofen Modified-Release Tablets 800 mg
A Phase 1 study testing Ibuprofen Tablets in people with Chronic Pain, run by Overseas Pharmaceuticals, Ltd. at 1 site in China.
Trial summary
An open-label, randomized, 3-way crossover study to evaluate the pharmacokinetics of investigational product "Ibuprofen Modified-Release Tablets 800 mg" in comparison to the reference standard "Ibuprofen Regular-Release Tablets 600 mg/800 mg" in normal healthy volunteers Primary objective: To evaluate the food effect… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Ibuprofen Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2020to 18 Jul 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects whose body mass index (BMI) at screening is within a range of ≥18.5 kg/m2 and <25.0 kg/m2.
- BMI = Body Weight (kg) / [Height (m)]2 And body weight is not less than 50 kg and 45 kg for males and females, respectively.
- Subject's medical history shows no contraindication to the test medications (hypersensitivity to ibuprofen or any component of test and reference products) and non-steroidal anti-inflammatory drugs (NSAIDs).
- Subjects who are judged to be in good health by the investigator based upon the results of physical examination (PE), vital signs, and routine laboratory tests.
- The female subject shows negative pregnancy test results within 30 days prior to the first dose of the study.
- The subject did not take any of the following medications in the specified durations:
Show all 9Show fewer
- Any systemically absorbed medication within 14 days (excluding vitamins, food supplements and hormone contraceptives not ibuprofen drug interactions) prior to the first dose of the study
- Any enzyme inducer/inhibitor and/or known hepatic or renal clearance-altering agents (e.g., erythromycin, cimetidine, barbiturates, phenothiazine, clarithromycin, troleandomycin, ketoconazole, miconazolem fluconazole, itraconazole) within 30 days prior to the first dose of the study.
- Subjects are willing to comply with protocol-stated requirements, instructions and restrictions, followed by understanding and signing the written informed consent form by the subject or legal representative if he/she is under the statutory age of consent as per the local authority.
Who cannot join
- Subjects with any properly diagnosed disease within 30 days prior to the first dose of the study.
- Subjects with a clinically significant hematological, endocrine, cardiovascular, hepatic, renal, gastrointestinal, and/or pulmonary disorder; subjects with any predisposing condition that might interfere with the absorption, distribution, metabolism and excretion of drugs; subjects who has had any previous gastrointestinal surgery or coronary artery bypass graft.
- Subjects who require treatment with any medications, either prescription or non-prescription (excluding vitamins and food supplements), within 30 days prior to the first dose of the study
- Subjects have participated in investigational drug trials and took any investigational drug within 60 days prior to the first does of the study.
- Subjects had blood donation more than 250 and 500 mL within 60 and 90 days, respectively prior to the first dose of the study.
- Subjects had a history of drug abuse or alcohol abuse according to the Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria.
Show all 15Show fewer
- Subjects cannot stop smoking and caffeine-intakes for 48 hours prior to the first dose of the study and during the entire study period.
- Subjects who are pregnant or lactating.
- Subjects who have been tested positive for the following tests:
- Human immunodeficiency virus (HIV)
- Hepatitis B virus (HBV)
- Hepatitis C virus (HCV)
- Treponema pallidum (STS test)
- For enrollment of female subjects with child-bearing potential, the subject must be practicing sexual abstinence or be using and willing to continue to use a medically acceptable form of birth control for at least 30 days prior to screening (that period will extend to 3 months for oral contraceptive use) and for at least 30 days after the last dose of study drug. For a subject to be considered not to be of child-bearing potential, she must have been amenorrheic for at least 2 years, or must have had a hysterectomy, a bilateral tubal ligation, and/or a bilateral oophorectomy (as determined by the medical history). The male partner of a female study subject with childbearing potential must use a condom and ensure that his partner uses a suitable method of contraception as outlined above.
- Subjects with underlying medical, mental, psychological, or other inappropriate conditions that would impair treatment compliance, or in the opinion of the investigator would not permit to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, 3-way Crossover Study to Evaluate the Pharmacokinetics of Investigational Product Ibuprofen Modified-Release Tablets 800 mg Compared to Ibuprofen Tablets 800 mg in Healthy Volunteers
An open-label, randomized, 3-way crossover study to evaluate the pharmacokinetics of investigational product "Ibuprofen Modified-Release Tablets 800 mg" in comparison to the reference standard "Ibuprofen Regular-Release Tablets 600 mg/800 mg" in normal healthy volunteers
Primary objective:
Read more
To evaluate the food effect of IBUMR and its bioavailability of single and multiple doses compared with reference drugs in normal healthy volunteers.
Secondary objectives:
- To determine and compare the single and multiple dose PK profiles of IBUMR and reference drugs.
- To identify the effect duration for IBUMR after dose administration by detecting ibuprofen concentrations in plasma.
- To evaluate the safety profile of single and multiple doses of IBUMR.
Read the detailed description
This study consists of 3 treatment periods as below. For Treatment A and Treatment B, single- and multiple-dose stages are included.
Treatment A:
One tablet of IBUMR will be administered to the subjects under fasted condition, followed by a minimum of 72-hour washout interval. After the washout period, subjects will receive 1 × IBUMR every 12 hours for a total of 8 doses.
Treatment B:
One tablet of IBURed-800mg will be administered to the subjects under fasted condition, followed by a minimum of 72-hour washout interval. After the washout period, subjects will receive 1 × IBURed-600mg every 8 hours for a total of 12 doses.
Treatment C:
Single dose of IBUMR will be given to the subjects under fed condition (a standard high-fat, high calorie breakfast should be consumed within 30 minutes prior to dosing).
A minimum of 3-day washout interval will be introduced across the 3 treatment periods. Subjects will be required to be fasted for at least 10 hours prior to the administration of morning doses.
- Conditions
- Chronic Pain
- Being tested
- Ibuprofen Tablets
- Keywords
- Ibuprofen Modified-Release Tablets, Overseas Pharmaceuticals, pain relief
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen TabletsDrug
Treatment A:
One tablet of IBUMR will be administered to the subjects under fasted condition, followed by a minimum of 72-hour washout interval. After the washout period, subjects will receive 1 × IBUMR every 12 hours for a total of 7 doses.
Treatment B:
One tablet of IBURed will be administered to the subjects under fasted condition, followed by a minimum of 72-hour washout interval. After the washout period, subjects will receive 1 × IBURed every 8 hours for a total of 10 doses.
Treatment C:
Single dose of IBUMR will be given to the subjects under fed condition (a standard high-fat, high calorie breakfast should be consumed within 30 minutes prior to dosing).
| Study group | Role | What they receive |
|---|---|---|
| Treatment ABC | Experimental | Receive the investigational product and active comparator in a sequence of treatment A, treatment B and treatment C. Receives: Drug: Ibuprofen Tablets |
| Treatment ACB | Experimental | Receive the investigational product and active comparator in a sequence of treatment A, treatment C and treatment B. Receives: Drug: Ibuprofen Tablets |
| Treatment BAC | Experimental | Receive the investigational product and active comparator in a sequence of treatment B, treatment A and treatment C. Receives: Drug: Ibuprofen Tablets |
| Treatment BCA | Experimental | Receive the investigational product and active comparator in a sequence of treatment B, treatment C and treatment A. Receives: Drug: Ibuprofen Tablets |
| Treatment CAB | Experimental | Receive the investigational product and active comparator in a sequence of treatment C, treatment A and treatment B. Receives: Drug: Ibuprofen Tablets |
| Treatment CBA | Experimental | Receive the investigational product and active comparator in a sequence of treatment C, treatment B and treatment A. Receives: Drug: Ibuprofen Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of single-dose and multiple-dose bioavailability between IBUMR and IBURed
Comparison of single-dose and multiple-dose bioavailability between IBUMR and IBURed in log-transformed values of area under the curve from time 0 to the last measurable concentration (AUCL)
Measured: After collecting blood samples from the last participant, up to 30 days
Comparison of single-dose and multi-dose bioavailability of IBUMR and IBURed
Comparison of single-dose and multiple-dose bioavailability between IBUMR and IBURed in log-transformed values of the peak concentration (Cmax)
Measured: After collecting blood samples from the last participant, up to 30 days
Comparison of single - and multi-dose bioavailability of IBUMR and IBURed
Comparison of single-dose and multiple-dose bioavailability between IBUMR and IBURed in log-transformed values of area under the curve from time 0 to infinity (AUCinf).
Measured: After collecting blood samples from the last participant, up to 30 days
To assess the food effect of IBUMR in the PK parameters
To assess the food effect of IBUMR in the PK parameters including Cmax
Measured: After collecting blood samples from the last participant, up to 30 days
To evaluate the food effect of IBUMR on PK parameters
To assess the food effect of IBUMR in the PK parameters including time to reach peak concentration (Tmax)
Measured: After collecting blood samples from the last participant, up to 30 days
To evaluate the food effects of IBUMR on PK parameters
To assess the food effect of IBUMR in the PK parameters including AUCL
Measured: After collecting blood samples from the last participant, up to 30 days
Evaluate the food effect of IBUMR in PK parameters
To assess the food effect of IBUMR in the PK parameters including AUCinf
Measured: After collecting blood samples from the last participant, up to 30 days
Determine the food effect of IBUMR in PK parameters
To assess the food effect of IBUMR in the PK parameters including elimination half-life (t1/2)
Measured: After collecting blood samples from the last participant, up to 30 days
Secondary outcomes (23)
Single-dose PK measures
-- Time to reach peak concentration (Tmax)
Measured: After collecting blood samples from the last participant, up to 30 days
Single dose PK method
-- Area under the concentration-time curve within time span t1 to t2 (AUCt1→t2)
Measured: After collecting blood samples from the last participant, up to 30 days
Single dose PK
-- Area under the concentration-time curve extrapolated from the last detectable sampling time point to infinity as a percentage of total AUC (AUCextrap)
Measured: After collecting blood samples from the last participant, up to 30 days
Single dose PK step
-- Elimination half-life (t1/2)
Measured: After collecting blood samples from the last participant, up to 30 days
Single dose PK design
-- Apparent oral clearance (CL/F)
Measured: After collecting blood samples from the last participant, up to 30 days
Single dose PK moves
-- Apparent volume of distribution after oral administration (Vd/F)
Measured: After collecting blood samples from the last participant, up to 30 days
Multiple-dose PK measures
-- Peak concentration at steady state (Cmax,ss)
Measured: After collecting blood samples from the last participant, up to 30 days
Multiple - dosed PK
-- Plasma drug concentration at a specified time t steady state (Ct,ss)
Measured: After collecting blood samples from the last participant, up to 30 days
Multiple - dosed PK method
-- Average concentration at steady state (Cavg)
Measured: After collecting blood samples from the last participant, up to 30 days
Multiple - dosed PK steps
-- Trough plasma concentration at steady state (Ctrough)
Measured: After collecting blood samples from the last participant, up to 30 days
Multiple - dosed PK design
-- Time to reach peak concentration at steady state (Tmax,ss)
Measured: After collecting blood samples from the last participant, up to 30 days
Multiple - dosed PK plan
-- Area under the concentration-time curve within time span t1 to t2 at steady state (AUCt1→t2,ss)
Measured: After collecting blood samples from the last participant, up to 30 days
Multiple - dosed PK program
-- AUC in 1 dosing interval (AUCτ) at steady state
Measured: After collecting blood samples from the last participant, up to 30 days
Multiple - dosed PK process
-- Terminal half-life at steady state (t1/2,ss)
Measured: After collecting blood samples from the last participant, up to 30 days
Multiple - dosed PK arrangement
-- Apparent oral clearance at steady state (CL/Fss)
Measured: After collecting blood samples from the last participant, up to 30 days
Multiple - dosed PK planning
-- Apparent volume of distribution after oral administration at steady state (Vd/Fss)
Measured: After collecting blood samples from the last participant, up to 30 days
Assessment of effect duration for IBUMR
-- For the plasma ibuprofen concentration of IBUMR at steady state, the time to drop to the Ctrough of IBURed-600mg will be calculated.
Measured: After collecting blood samples from the last participant, up to 30 days
Evaluation of duration of IBUMR effect
-- Percentage of the test drug-treated subjects with higher or equal plasma ibuprofen concentrations at 12-hour at steady state (C12,ss) compared to the Ctrough of IBURed-600mg will be calculated.
Measured: After collecting blood samples from the last participant, up to 30 days
Incidence of treatment-emergent adverse events (safety and tolerability)
Incidence of AEs and SAEs
Measured: After collecting blood samples from the last participant, up to 60 days
safety and tolerability
incidence of abnormal Physical examination
Measured: After collecting blood samples from the last participant, up to 60 days
Incidence of treatment-emergent adverse events
abnormal Vital signs
Measured: After collecting blood samples from the last participant, up to 60 days
Incidence of sudden adverse events (safety and tolerability)
abnormal laboratory tests results
Measured: After collecting blood samples from the last participant, up to 60 days
Incidence of treatment-induced adverse events (safety and tolerability)
abnormal 12-lead ECG exams
Measured: After collecting blood samples from the last participant, up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start24 Dec 2020
- Primary completion6 Feb 2021
- Study completion18 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- An open label, randomized, single and multiple-dose, test-versus-reference drug, fed-versus-fasted, 3-way crossover study.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Overseas Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ming-Che Liu, M.D, Principal investigator, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329454
- Sponsor's protocol ID
- OVEIBUA20181121
- Status last verified
- Dec 2021
- First submitted
- 4 Feb 2021
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Albert KS, Gernaat CM. Pharmacokinetics of ibuprofen. Am J Med. 1984 Jul 13;77(1A):40-6. doi: 10.1016/s0002-9343(84)80017-0.
PubMed 6465162Albert KS, Gillespie WR, Wagner JG, Pau A, Lockwood GF. Effects of age on the clinical pharmacokinetics of ibuprofen. Am J Med. 1984 Jul 13;77(1A):47-50. doi: 10.1016/s0002-9343(84)80018-2.
PubMed 6380280Barkin RL, Buvanendran A. Focus on the COX-1 and COX-2 agents: renal events of nonsteroidal and anti-inflammatory drugs-NSAIDs. Am J Ther. 2004 Mar-Apr;11(2):124-9. doi: 10.1097/00045391-200403000-00007.
PubMed 14999364Davies NM. Clinical pharmacokinetics of ibuprofen. The first 30 years. Clin Pharmacokinet. 1998 Feb;34(2):101-54. doi: 10.2165/00003088-199834020-00002.
PubMed 9515184Goldberg DS, McGee SJ. Pain as a global public health priority. BMC Public Health. 2011 Oct 6;11:770. doi: 10.1186/1471-2458-11-770.
PubMed 21978149Legg T, Paluch E, Jayawardena S. Single- and Multiple-Dose Pharmacokinetics of Immediate-Release/Extended-Release Ibuprofen Tablets. Clin Pharmacol Drug Dev. 2017 Jan;6(1):36-43. doi: 10.1002/cpdd.288. Epub 2016 Sep 22.
PubMed 27364900Devarakonda K, Kostenbader K, Giuliani MJ, Young JL. Single- and multiple-dose pharmacokinetics of biphasic immediate-release/extended-release hydrocodone bitartrate/acetaminophen (MNK-155) compared with immediate-release hydrocodone bitartrate/ibuprofen and immediate-release tramadol HCl/acetaminophen. J Pain Res. 2015 Sep 30;8:647-56. doi: 10.2147/JPR.S83416. eCollection 2015.
PubMed 26508885O'Connor TP, Anderson AM, Lennox B, Muldoon C. A novel sustained-release formulation of ibuprofen provides effective once-daily therapy in the treatment of rheumatoid arthritis and osteoarthritis. Br J Clin Pract. 1993 Jan-Feb;47(1):10-3.
PubMed 8461240Varrassi G, Pergolizzi JV, Dowling P, Paladini A. Ibuprofen Safety at the Golden Anniversary: Are all NSAIDs the Same? A Narrative Review. Adv Ther. 2020 Jan;37(1):61-82. doi: 10.1007/s12325-019-01144-9. Epub 2019 Nov 8.
PubMed 31705437Volans G, Hartley V, McCrea S, Monaghan J. Non-opioid analgesic poisoning. Clin Med (Lond). 2003 Mar-Apr;3(2):119-23. doi: 10.7861/clinmedicine.3-2-119. No abstract available.
PubMed 12737366
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, 3-way Crossover Study to Evaluate the Pharmacokinetics of Investigational Product Ibuprofen Modified-Release Tablets 800 mg Compared to Ibuprofen Tablets 800 mg in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05329454
- Acronym / sponsor ID
- OVEIBUA20181121
- Conditions
- Chronic Pain
- Keywords
- Ibuprofen Modified-Release Tablets, Overseas Pharmaceuticals, pain relief
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Overseas Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Dec 2020 (actual)
- Primary completion
- 6 Feb 2021 (actual)
- Study completion
- 18 Jul 2021 (actual)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label, randomized, 3-way crossover study to evaluate the pharmacokinetics of investigational product "Ibuprofen Modified-Release Tablets 800 mg" in comparison to the reference standard "Ibuprofen Regular-Release Tablets 600 mg/800 mg" in normal healthy volunteers
Primary objective:
To evaluate the food effect of IBUMR and its bioavailability of single and multiple doses compared with reference drugs in normal healthy volunteers.
Secondary objectives:
- To determine and compare the single and multiple dose PK profiles of IBUMR and reference drugs.
- To identify the effect duration for IBUMR after dose administration by detecting ibuprofen concentrations in plasma.
- To evaluate the safety profile of single and multiple doses of IBUMR.
Detailed description
This study consists of 3 treatment periods as below. For Treatment A and Treatment B, single- and multiple-dose stages are included.
Treatment A:
One tablet of IBUMR will be administered to the subjects under fasted condition, followed by a minimum of 72-hour washout interval. After the washout period, subjects will receive 1 × IBUMR every 12 hours for a total of 8 doses.
Treatment B:
One tablet of IBURed-800mg will be administered to the subjects under fasted condition, followed by a minimum of 72-hour washout interval. After the washout period, subjects will receive 1 × IBURed-600mg every 8 hours for a total of 12 doses.
Treatment C:
Single dose of IBUMR will be given to the subjects under fed condition (a standard high-fat, high calorie breakfast should be consumed within 30 minutes prior to dosing).
A minimum of 3-day washout interval will be introduced across the 3 treatment periods. Subjects will be required to be fasted for at least 10 hours prior to the administration of morning doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- An open label, randomized, single and multiple-dose, test-versus-reference drug, fed-versus-fasted, 3-way crossover study.
| Arm | Type | Receives |
|---|---|---|
| Treatment ABC | Experimental | Drug: Ibuprofen TabletsReceive the investigational product and active comparator in a sequence of treatment A, treatment B and treatment C. |
| Treatment ACB | Experimental | Drug: Ibuprofen TabletsReceive the investigational product and active comparator in a sequence of treatment A, treatment C and treatment B. |
| Treatment BAC | Experimental | Drug: Ibuprofen TabletsReceive the investigational product and active comparator in a sequence of treatment B, treatment A and treatment C. |
| Treatment BCA | Experimental | Drug: Ibuprofen TabletsReceive the investigational product and active comparator in a sequence of treatment B, treatment C and treatment A. |
| Treatment CAB | Experimental | Drug: Ibuprofen TabletsReceive the investigational product and active comparator in a sequence of treatment C, treatment A and treatment B. |
| Treatment CBA | Experimental | Drug: Ibuprofen TabletsReceive the investigational product and active comparator in a sequence of treatment C, treatment B and treatment A. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects whose body mass index (BMI) at screening is within a range of ≥18.5 kg/m2 and <25.0 kg/m2.
- BMI = Body Weight (kg) / [Height (m)]2 And body weight is not less than 50 kg and 45 kg for males and females, respectively.
- Subject's medical history shows no contraindication to the test medications (hypersensitivity to ibuprofen or any component of test and reference products) and non-steroidal anti-inflammatory drugs (NSAIDs).
- Subjects who are judged to be in good health by the investigator based upon the results of physical examination (PE), vital signs, and routine laboratory tests.
- The female subject shows negative pregnancy test results within 30 days prior to the first dose of the study.
Key exclusion criteria (15 listed)
- Subjects with any properly diagnosed disease within 30 days prior to the first dose of the study.
- Subjects with a clinically significant hematological, endocrine, cardiovascular, hepatic, renal, gastrointestinal, and/or pulmonary disorder; subjects with any predisposing condition that might interfere with the absorption, distribution, metabolism and excretion of drugs; subjects who has had any previous gastrointestinal surgery or coronary artery bypass graft.
- Subjects who require treatment with any medications, either prescription or non-prescription (excluding vitamins and food supplements), within 30 days prior to the first dose of the study
- Subjects have participated in investigational drug trials and took any investigational drug within 60 days prior to the first does of the study.
- Subjects had blood donation more than 250 and 500 mL within 60 and 90 days, respectively prior to the first dose of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofen TabletsTreatment A: One tablet of IBUMR will be administered to the subjects under fasted condition, followed by a minimum of 72-hour washout interval. After the washout period, subjects will receive 1 × IBUMR every 12 hours for a total of 7 doses. Treatment B: One tablet of IBURed will be administered to the subjects under fasted condition, followed by a minimum of 72-hour washout interval. After the washout period, subjects will receive 1 × IBURed every 8 hours for a total of 10 doses. Treatment C: Single dose of IBUMR will be given to the subjects under fed condition (a standard high-fat, high calorie breakfast should be consumed within 30 minutes prior to dosing). | Drug | Treatment ABC, Treatment ACB, Treatment BAC, Treatment BCA, Treatment CAB, Treatment CBA |
Primary outcome
Comparison of single-dose and multiple-dose bioavailability between IBUMR and IBURed
Time frame: After collecting blood samples from the last participant, up to 30 days
Comparison of single-dose and multiple-dose bioavailability between IBUMR and IBURed in log-transformed values of area under the curve from time 0 to the last measurable concentration (AUCL)
Comparison of single-dose and multi-dose bioavailability of IBUMR and IBURed
Time frame: After collecting blood samples from the last participant, up to 30 days
Comparison of single-dose and multiple-dose bioavailability between IBUMR and IBURed in log-transformed values of the peak concentration (Cmax)
Comparison of single - and multi-dose bioavailability of IBUMR and IBURed
Time frame: After collecting blood samples from the last participant, up to 30 days
Comparison of single-dose and multiple-dose bioavailability between IBUMR and IBURed in log-transformed values of area under the curve from time 0 to infinity (AUCinf).
To assess the food effect of IBUMR in the PK parameters
Time frame: After collecting blood samples from the last participant, up to 30 days
To assess the food effect of IBUMR in the PK parameters including Cmax
To evaluate the food effect of IBUMR on PK parameters
Time frame: After collecting blood samples from the last participant, up to 30 days
To assess the food effect of IBUMR in the PK parameters including time to reach peak concentration (Tmax)
To evaluate the food effects of IBUMR on PK parameters
Time frame: After collecting blood samples from the last participant, up to 30 days
To assess the food effect of IBUMR in the PK parameters including AUCL
Evaluate the food effect of IBUMR in PK parameters
Time frame: After collecting blood samples from the last participant, up to 30 days
To assess the food effect of IBUMR in the PK parameters including AUCinf
Determine the food effect of IBUMR in PK parameters
Time frame: After collecting blood samples from the last participant, up to 30 days
To assess the food effect of IBUMR in the PK parameters including elimination half-life (t1/2)
23 secondary outcomes
Single-dose PK measures
Time frame: After collecting blood samples from the last participant, up to 30 days
Single dose PK method
Time frame: After collecting blood samples from the last participant, up to 30 days
Single dose PK
Time frame: After collecting blood samples from the last participant, up to 30 days
Single dose PK step
Time frame: After collecting blood samples from the last participant, up to 30 days
Single dose PK design
Time frame: After collecting blood samples from the last participant, up to 30 days
Single dose PK moves
Time frame: After collecting blood samples from the last participant, up to 30 days
Multiple-dose PK measures
Time frame: After collecting blood samples from the last participant, up to 30 days
Multiple - dosed PK
Time frame: After collecting blood samples from the last participant, up to 30 days
Multiple - dosed PK method
Time frame: After collecting blood samples from the last participant, up to 30 days
Multiple - dosed PK steps
Time frame: After collecting blood samples from the last participant, up to 30 days
Multiple - dosed PK design
Time frame: After collecting blood samples from the last participant, up to 30 days
Multiple - dosed PK plan
Time frame: After collecting blood samples from the last participant, up to 30 days
Multiple - dosed PK program
Time frame: After collecting blood samples from the last participant, up to 30 days
Multiple - dosed PK process
Time frame: After collecting blood samples from the last participant, up to 30 days
Multiple - dosed PK arrangement
Time frame: After collecting blood samples from the last participant, up to 30 days
Multiple - dosed PK planning
Time frame: After collecting blood samples from the last participant, up to 30 days
Assessment of effect duration for IBUMR
Time frame: After collecting blood samples from the last participant, up to 30 days
Evaluation of duration of IBUMR effect
Time frame: After collecting blood samples from the last participant, up to 30 days
Incidence of treatment-emergent adverse events (safety and tolerability)
Time frame: After collecting blood samples from the last participant, up to 60 days
safety and tolerability
Time frame: After collecting blood samples from the last participant, up to 60 days
Incidence of treatment-emergent adverse events
Time frame: After collecting blood samples from the last participant, up to 60 days
Incidence of sudden adverse events (safety and tolerability)
Time frame: After collecting blood samples from the last participant, up to 60 days
Incidence of treatment-induced adverse events (safety and tolerability)
Time frame: After collecting blood samples from the last participant, up to 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Background: PubMed 6465162Albert KS, Gernaat CM. Pharmacokinetics of ibuprofen. Am J Med. 1984 Jul 13;77(1A):40-6. doi: 10.1016/s0002-9343(84)80017-0.
- Background: PubMed 6380280Albert KS, Gillespie WR, Wagner JG, Pau A, Lockwood GF. Effects of age on the clinical pharmacokinetics of ibuprofen. Am J Med. 1984 Jul 13;77(1A):47-50. doi: 10.1016/s0002-9343(84)80018-2.
- Background: PubMed 14999364Barkin RL, Buvanendran A. Focus on the COX-1 and COX-2 agents: renal events of nonsteroidal and anti-inflammatory drugs-NSAIDs. Am J Ther. 2004 Mar-Apr;11(2):124-9. doi: 10.1097/00045391-200403000-00007.
- Background: PubMed 9515184Davies NM. Clinical pharmacokinetics of ibuprofen. The first 30 years. Clin Pharmacokinet. 1998 Feb;34(2):101-54. doi: 10.2165/00003088-199834020-00002.
- Background: PubMed 21978149Goldberg DS, McGee SJ. Pain as a global public health priority. BMC Public Health. 2011 Oct 6;11:770. doi: 10.1186/1471-2458-11-770.
- Background: PubMed 27364900Legg T, Paluch E, Jayawardena S. Single- and Multiple-Dose Pharmacokinetics of Immediate-Release/Extended-Release Ibuprofen Tablets. Clin Pharmacol Drug Dev. 2017 Jan;6(1):36-43. doi: 10.1002/cpdd.288. Epub 2016 Sep 22.
- Background: PubMed 26508885Devarakonda K, Kostenbader K, Giuliani MJ, Young JL. Single- and multiple-dose pharmacokinetics of biphasic immediate-release/extended-release hydrocodone bitartrate/acetaminophen (MNK-155) compared with immediate-release hydrocodone bitartrate/ibuprofen and immediate-release tramadol HCl/acetaminophen. J Pain Res. 2015 Sep 30;8:647-56. doi: 10.2147/JPR.S83416. eCollection 2015.
- Background: PubMed 8461240O'Connor TP, Anderson AM, Lennox B, Muldoon C. A novel sustained-release formulation of ibuprofen provides effective once-daily therapy in the treatment of rheumatoid arthritis and osteoarthritis. Br J Clin Pract. 1993 Jan-Feb;47(1):10-3.
- Background: PubMed 31705437Varrassi G, Pergolizzi JV, Dowling P, Paladini A. Ibuprofen Safety at the Golden Anniversary: Are all NSAIDs the Same? A Narrative Review. Adv Ther. 2020 Jan;37(1):61-82. doi: 10.1007/s12325-019-01144-9. Epub 2019 Nov 8.
- Background: PubMed 12737366Volans G, Hartley V, McCrea S, Monaghan J. Non-opioid analgesic poisoning. Clin Med (Lond). 2003 Mar-Apr;3(2):119-23. doi: 10.7861/clinmedicine.3-2-119. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming-Che Liu, M.D principal investigator
Taipei Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ibuprofen Tablets in people with Chronic Pain, run by Overseas Pharmaceuticals, Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of single-dose and multiple-dose bioavailability between IBUMR and IBURed (time frame: After collecting blood samples from the last participant, up to 30 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05329454, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.