Pain, HeadPhase 1NCT03429738
Single-Dose Bioavailability Study of Two Formulations of Ibuprofen and Pseudoephedrine Hydrochloride Tablets
A Phase 1 study testing Ibuprofen/Pseudoephedrine HCl 200/30 mg Film-Coated Tablets and RhinAdvil Rhume 200 mg/30 mg Film-Coated Tablets in people with Pain, Head and Pain, Acute, run by Institut für Pharmakologie und Präventive Medizin at 1 site in Canada.
Trial summary
Evaluation of the comparative bioavailability between two oral formulations containing ibuprofen 200 mg and pseudoephedrine 30 mg after a single dose in healthy subjects under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Head, Pain, Acute, Pain, Back
- What is being tested?
- Ibuprofen/Pseudoephedrine HCl 200/30 mg Film-Coated Tablets and RhinAdvil Rhume 200 mg/30 mg Film-Coated Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteCanada
- Study dates
- 27 Apr 2014to 5 May 2014
- 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
- Healthy, non-smoking, male and female subjects, 18 years of age or older.
- BMI ≥ 18.5 and 30.0 kg/m2
- No clinically significant findings in vital signs measurements.
- No clinically significant abnormal laboratory values.
- No clinically significant findings in a 12-lead electrocardiogram (ECG).
- No significant diseases.
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- Willing to use an acceptable, effective method of contraception.
- Be informed of the nature of the study and give written consent prior to any study procedure.
- Have no clinically significant findings from a physical examination.
Who cannot join
- Known history or presence of any clinically significant medical condition.
- Known or suspected carcinoma.
- History or presence of ulcerative colitis, diverticulosis, Crohn's disease, or gastrointestinal ulcer, perforation, or haemorrhage.
- Known history or presence of auto-immune disorders, gastrointestinal toxicity, or a risk of gastrointestinal bleeding or gastrointestinal tract irritation.
- Known history or presence of cardiovascular disease, heart failure, tachycardia, hypertension, angina pectoris, hyperthyroidism, psychosis, seizures, risk of urinary retention, diabetes, phaeochromocytoma, closed angle glaucoma, chronic rhinitis, or prostatic enlargement.
- Known history or presence of angioedema.
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- Known history or presence of galactose or fructose intolerance, sucraseisomaltase insufficiency, Lapp lactase insufficiency, galactosemia, or glucose-galactose malabsorption syndrome.
- Known history of severe skin reactions (e.g. exfoliative dermatitis, SJS, and TEN).
- Known history or presence of bronchial asthma or allergic disease resulting in bronchospasm.
- Presence of hepatic or renal dysfunction.
- Presence of clinically significant gastrointestinal disease or history of malabsorption within the last year.
- Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption.
- History of drug or alcohol addiction requiring treatment.
- History of gastrointestinal bleeding or perforation when previously taking NSAIDs.
- Positive test result for HIV, Hepatitis B surface antigen or Hepatitis C antibody.
- Positive test result for urine drugs of abuse (cannabinoids, opiates, amphetamines, cocaine, phencyclidine, tricyclic antidepressants, barbiturates, methadone and benzodiazepines) or urine cotinine.
- Difficulty fasting or consuming standard meals.
- Does not tolerate venipuncture.
- Use of tobacco or nicotine-containing products within 6 months prior to drug administration.
- On a special diet within 30 days prior to drug administration (e.g., liquid, protein, raw food diet).
- Participated in another clinical trial or received an investigational product within 30 days prior to drug administration.
- Donation or loss of whole blood (including clinical trials):
- 50 mL and ≤ 499 mL within 30 days prior to drug administration
- 500 mL within 56 days prior to drug administration.
- Females who:
- Have discontinued or changed the use of implanted, intrauterine, intravaginal, or injected hormonal contraceptives within 6 months prior to dosing; Have discontinued or changed the use of oral or patch hormonal contraceptives within 1 month prior to drug administration; Are pregnant (serum hCG consistent with pregnancy); or Are lactating.
- Have had a tattoo or body piercing within 30 days prior to drug administration.
- Known history or presence of hypersensitivity or idiosyncratic reaction to ibuprofen, pseudoephedrine, NSAIDs, or any other drug substances with similar activity or any of the excipients in the drug products
- Use of drugs in the phenethylamine and amphetamine chemical classes within 14 days prior to drug administration.
- Use of NSAIDs (including cyclo-oxygenase-2 selective inhibitors) aspirin, corticosteroids, anticoagulants, selective serotonin-reuptake inhibitors, antihypertensives, diuretics, cardiac glycosides, lithium, methotrexate, cyclosporin, mifepristone, tacrolimus, zidovudine, linezolid, dopaminergic alkaloids, quinolone antibiotics, terpene derivatives, clobutinol, atropine, local anaesthetics, MAO inhibitors, vasoconstrictors, alpha sympathomimetic drugs, or anti-platelet agents within 30 days prior to drug administration.
- Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to drug administration. (e.g. barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole, antidepressants (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose, Comparative Bioavailability Study of Two Formulations of Ibuprofen and Pseudoephedrine Hydrochloride 200 mg/30 mg Tablets Under Fasting Conditions
Evaluation of the comparative bioavailability between two oral formulations containing ibuprofen 200 mg and pseudoephedrine 30 mg after a single dose in healthy subjects under fasting conditions.
Read the detailed description
Ibuprofen is one of the most often used non steroidal antiinflammatory drug (NSAR) in the management of mild to moderate pain and inflammation. Combined with the sympathomimetic pseudoephedrine as decongestant it is widely used in colds or fever. The purpose of this phase-I-study was to evaluate the comparative bioavailability between a combination of 200 mg ibuprofen and 30 mg pseudoephedrine film-coated tablets to the reference formulation RhinAdvil Rhume® 200 mg/30 mg (Wyeth Santé Familiale, France).
- Conditions
- Pain, Head, Pain, Acute, Pain, Back, Fever
- Being tested
- Ibuprofen/Pseudoephedrine HCl 200/30 mg Film-Coated Tablets, RhinAdvil Rhume 200 mg/30 mg Film-Coated Tablets
- Keywords
- Ibuprofen, phase-I-study, pharmacokinetic, combination therapy, bioavailability, bioequivalence, pseudoephedrine hydrochloride
- Medical subject headings
- Headache, Acute Pain, Back Pain, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen/Pseudoephedrine HCl 200/30 mg Film-Coated TabletsDrug
Also called Ibuprofen/Pseudoephedrine/test product
Experimental drug
RhinAdvil Rhume 200 mg/30 mg Film-Coated TabletsDrug
Also called RhinAdvil
Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| Experimental Drug | Experimental | Drug: Ibuprofen/Pseudoephedrine HCl 200/30 mg Film-Coated Tablets Temmler Werke GmbH/ Part of Aenova Group, Germany, Intervention: one tablet administered after an overnight fast of at least 10 hours Receives: Drug: Ibuprofen/Pseudoephedrine HCl 200/30 mg Film-Coated Tablets |
| Active Comparator | Active comparator | Active Comparator: RhinAdvil Rhume 200 mg/30 mg Film-Coated Tablets Wyeth Santé Familiale, France, Intervention: one tablet administered after an overnight fast of at least 10 hours Receives: Drug: RhinAdvil Rhume 200 mg/30 mg Film-Coated Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-t) (area under the analyte concentration versus time curve) of ibuprofen and pseudoephedrine, respectively
The 90% confidence intervals of the relative mean plasma (1S,2S)- pseudoephedrine and (S) ibuprofen AUC should be between 80.00 and 125.00%
Measured: 7 days (± 3 hours)
maximum serum concentration of ibuprofen and pseudoephedrine, respectively
The 90% confidence intervals of the relative mean plasma (1S,2S)- pseudoephedrine and (S) ibuprofen Cmax should be between 80.00 and 125.00%
Measured: 7 days (± 3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start27 Apr 2014
- Primary completion5 May 2014
- Study completion5 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, HeadStudies 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
- open-label, single-dose, randomized, two-period, two-treatment, twosequence, crossover, comparative bioavailability study.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut für Pharmakologie und Präventive Medizin
- Sponsor type
- Research network
- Collaborators
- Pharma Medica Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Latifa Yamlahi, MD, Study director, Pharma Medica Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429738
- Sponsor's protocol ID
- PMRI study number 2014-3489
- Status last verified
- Feb 2018
- First submitted
- 31 Jan 2018
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no IPD to be shared
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Comparative Bioavailability Study of Two Formulations of Ibuprofen and Pseudoephedrine Hydrochloride 200 mg/30 mg Tablets Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT03429738
- Acronym / sponsor ID
- PMRI study number 2014-3489
- Conditions
- Pain, Head, Pain, Acute, Pain, Back, Fever
- Keywords
- Ibuprofen, phase-I-study, pharmacokinetic, combination therapy, bioavailability, bioequivalence, pseudoephedrine hydrochloride
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Institut für Pharmakologie und Präventive MedizinResearch network
- Collaborators
- Pharma Medica Research, Inc.
- Study start
- 27 Apr 2014 (actual)
- Primary completion
- 5 May 2014 (actual)
- Study completion
- 5 May 2014 (actual)
- First posted
- 12 Feb 2018 (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.
Evaluation of the comparative bioavailability between two oral formulations containing ibuprofen 200 mg and pseudoephedrine 30 mg after a single dose in healthy subjects under fasting conditions.
Detailed description
Ibuprofen is one of the most often used non steroidal antiinflammatory drug (NSAR) in the management of mild to moderate pain and inflammation. Combined with the sympathomimetic pseudoephedrine as decongestant it is widely used in colds or fever. The purpose of this phase-I-study was to evaluate the comparative bioavailability between a combination of 200 mg ibuprofen and 30 mg pseudoephedrine film-coated tablets to the reference formulation RhinAdvil Rhume® 200 mg/30 mg (Wyeth Santé Familiale, France).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open-label, single-dose, randomized, two-period, two-treatment, twosequence, crossover, comparative bioavailability study.
| Arm | Type | Receives |
|---|---|---|
| Experimental Drug | Experimental | Drug: Ibuprofen/Pseudoephedrine HCl 200/30 mg Film-Coated TabletsDrug: Ibuprofen/Pseudoephedrine HCl 200/30 mg Film-Coated Tablets Temmler Werke GmbH/ Part of Aenova Group, Germany, Intervention: one tablet administered after an overnight fast of at least 10 hours |
| Active Comparator | Active comparator | Drug: RhinAdvil Rhume 200 mg/30 mg Film-Coated TabletsActive Comparator: RhinAdvil Rhume 200 mg/30 mg Film-Coated Tablets Wyeth Santé Familiale, France, Intervention: one tablet administered after an overnight fast of at least 10 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy, non-smoking, male and female subjects, 18 years of age or older.
- BMI ≥ 18.5 and 30.0 kg/m2
- No clinically significant findings in vital signs measurements.
- No clinically significant abnormal laboratory values.
- No clinically significant findings in a 12-lead electrocardiogram (ECG).
Key exclusion criteria (31 listed)
- Known history or presence of any clinically significant medical condition.
- Known or suspected carcinoma.
- History or presence of ulcerative colitis, diverticulosis, Crohn's disease, or gastrointestinal ulcer, perforation, or haemorrhage.
- Known history or presence of auto-immune disorders, gastrointestinal toxicity, or a risk of gastrointestinal bleeding or gastrointestinal tract irritation.
- Known history or presence of cardiovascular disease, heart failure, tachycardia, hypertension, angina pectoris, hyperthyroidism, psychosis, seizures, risk of urinary retention, diabetes, phaeochromocytoma, closed angle glaucoma, chronic rhinitis, or prostatic enlargement.
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/Pseudoephedrine HCl 200/30 mg Film-Coated TabletsAlso: Ibuprofen/Pseudoephedrine/test productExperimental drug | Drug | Experimental Drug |
| RhinAdvil Rhume 200 mg/30 mg Film-Coated TabletsAlso: RhinAdvilActive Comparator | Drug | Active Comparator |
Primary outcome
AUC(0-t) (area under the analyte concentration versus time curve) of ibuprofen and pseudoephedrine, respectively
Time frame: 7 days (± 3 hours)
The 90% confidence intervals of the relative mean plasma (1S,2S)- pseudoephedrine and (S) ibuprofen AUC should be between 80.00 and 125.00%
maximum serum concentration of ibuprofen and pseudoephedrine, respectively
Time frame: 7 days (± 3 hours)
The 90% confidence intervals of the relative mean plasma (1S,2S)- pseudoephedrine and (S) ibuprofen Cmax should be between 80.00 and 125.00%
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 12 Feb 2018.
- Individual participant dataSharing planned: No. no IPD to be shared
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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.
Latifa Yamlahi, MD study director
Pharma Medica Research, Inc.
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/Pseudoephedrine HCl 200/30 mg Film-Coated Tablets and RhinAdvil Rhume 200 mg/30 mg Film-Coated Tablets in people with Pain, Head and Pain, Acute, run by Institut für Pharmakologie und Präventive Medizin at 1 site in Canada.
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 31 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 12 Feb 2018. 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 Canada. 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?
AUC(0-t) (area under the analyte concentration versus time curve) of ibuprofen and pseudoephedrine, respectively (time frame: 7 days (± 3 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2018.