HealthyPhase 1NCT03561558
Bioequivalence Study of Ibuprofen D, Oral Suspension, 200 mg/5ml and Nurofen®, Oral Suspension 100 mg/5 ml in Healthy Volunteers Under Fasting Conditions
A Phase 1 study testing Ibuprofen D and Nurofen® for Children in people with Healthy, run by Pharmtechnology LLC at 1 site in Russia.
Trial summary
To demonstrate bioequivalence of single dose test formulation of Ibuprofen,oral suspension 200 mg/5 ml (containing ibuprofen 200 mg) of Pharmtechnology LLC, Republic of Belarus with reference Nurofen® for Children, oral suspension 100 mg / 5 ml (containing ibuprofen 100 mg) of "Reckitt Benckiser Healthcare… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ibuprofen D and Nurofen® for Children
- 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 siteRussia
- Study dates
- 11 Jun 2018to 25 Jun 2018
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult human subjects, aged between 18 to 45 years.
- Subjects with Body Mass Index (BMI) 18.5 to 30 kg/m2.
- Female subjects with a negative pregnancy test.
- Non-lactating females.
- If subject is a female and is of child bearing potential, she should be practicing an acceptable non-hormonal method of birth control for the duration of the study(at least 14 days before the start of the study, throughout the study and 14 days after the completion of the study), such as a combination of male condom and diaphragm with spermicide.
- If subject is a male and and has a female partner of child bearing potential, he should be practicing an acceptable method of birth control for the duration of the study(at least 14 days before the start of the study, throughout the study and 14 days after the completion of the study), such as a combination of male condom and spermicide (double barrier method).
- Subjects having no clinically significant medical history and no clinically significant abnormalities in general physical examination, laboratory assessments, 12-lead ECG, chest X-Ray or vital signs.
- Subjects are able to understand the requirements of the study, to sign a written informed consent, and also to accept all the restrictions imposed during the course of the study, and to agree to return for the required investigations.
Who cannot join
- Subjects with a known history of allergic disorders.
- Subjects with a known history of drug hypersensitivity to ibuprofen d or any excipients of the formulation.
- Subjects with a known history of drug intolerance.
- Subjects with history of psychiatric disorders.
- Subjects with history of epilepsy, seizures, other neurological disorders.
- Subjects on a low sodium diet for 2 weeks before the start study, or on any special diet (for example, vegetarian, vegan) or follow a special lifestyle (night shifts,extreme physical work).
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- Use of hormonal contraceptives either oral or implants within 6 months prior to first period dosing.
- Female subjects of child bearing potential who have had an unprotected sexual intercourse with an unsterilized male sexual partner within 30 days before the start of the study
- Use of any xanthine-containing food or beverages (tea, coffee, chocolates, soft drinks like cola, etc.) for at least 72 hours prior to the start of the study.
- Use of citrus fruits (including grapefruit and grapefruit juice) and cranberries (including juices,etc.) for at least 14 days prior to the start of the study.
- Subjects with a history of disorders of cardiovascular, bronchopulmonary, neuroendocrine system, and also the gastrointestinal tract, liver, kidney and blood.
- Subjects with a history of other disorders that, at the discretion of the Principal Investigator, can affect absorption, distribution, metabolism or excretion of both drugs or increase the risk of adverse effects.
- Subjects with a history of surgical interventions on the gastrointestinal tract except for appendectomy.
- Subjects with a history acute infectious illnesses within 4 weeks prior to the start of the study.
- Subjects with abnormalities in resting heart rate (>80 beats/min or <60 beats/min), blood pressure either hypotensive episode (systolic blood pressure <100 mmHg or diastolic blood pressure <70 mmHg) or hypertension (systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥90 mmHg), in ECG
- Use of known inhibitors or inducers of liver function, in particular isoenzyme CYP 3A4 (example of inducers: omeprazole, cimetidine, drugs, containing St. John's wort extract, barbiturates, carbamazepine, phenytoin, glucocorticoids; example of inhibitors: antiviral drugs, clarithromycin, ciprofloxacin, gestodene, etc.) within 2 months prior to the start of the study.
- Use of any drugs with systemic absorption within14 days prior to the start of the study.
- Use of OTC drugs, including herbs and nutritional supplements within 7 days prior to the Dosing Date. (including vitamins and natural food additives, phyto supplements,herbal preparations such as, cat's claw, angelica officinalis, oenothera, feverfew, garlic, ginger, ginkgo, red clover, horse chestnut, green tea, ginseng).
- Depot injection or implants of any drugs within 3 months prior to the start of the study.
- Donation of plasma or blood (450 ml or more) within 2 months prior to the start of the study.
- Intake of more than 10 units alcohol per week (1 unit of alcohol is equivalent to ½ liter of beer, 200 ml dry wine or 50 ml of spirits) or history alcoholism, drug addiction, drug abuse.
- Smoking more than 10 cigarettes per day.
- Participation in other clinical trials of medicines within 3 months prior to the start of the study.
- Positive test for syphilis, hepatitis B, hepatitis C or HIV.
- Positive pregnancy test (for female subjects with child bearing potential).
- Breast-feeding.
- Positive test for alcohol.
- Positive urinary screen test for drugs of abuse.
- Subjects with a history of a rare hereditary intolerance to galactose and/or sucrose, a deficiency of lactase, glucose-galactose malabsorption syndrome.
- Subjects with clinically significant abnormal laboratory values and results of imaging studies.
- Subjects who refuse to comply with the study protocol and/or not credible therein and who are, at the discretion of the Principal Investigator, unable to understand and assess the information about the study, expected risks and possible discomfort in the process of signing written informed consent.
Trial locations and contacts
1 site in 1 country.
Russia1 site
State Autonomous Healthcare Facility of the Yaroslavl Region "Clinical Hospital No. 2"
Yaroslavl, Yaroslavl Oblast, 150010
About this study
Official title: Open, Randomized, Cross-over, Two Period, Two-sequence, One-center, Bioequivalence Study of Ibuprofen D, Oral Suspension, 200 mg / 5ml (Pharmtechnology, Belarus) and Nurofen® for Children, Oral Suspension 100 mg / 5 ml (Reckitt Benckiser Healthcare International Ltd, UK) in Healthy Volunteers Under Fasting Conditions
To demonstrate bioequivalence of single dose test formulation of Ibuprofen,oral suspension 200 mg/5 ml (containing ibuprofen 200 mg) of Pharmtechnology LLC, Republic of Belarus with reference Nurofen® for Children, oral suspension 100 mg / 5 ml (containing ibuprofen 100 mg) of "Reckitt Benckiser Healthcare International Ltd, .", UK in normal, healthy, adult, human subjects under fasting conditions.To monitor adverse events and ensure the safety
Read the detailed description
Total 30 normal healthy adult subjects will be enrolled in the study. Subjects will be administered either the Test (5 ml of oral suspension containing 200 mg of ibuprofen) or the Reference Product (10ml of oral suspension containing 200 mg of ibuprofen) with 200 mL of water in each period as per the randomization schedule. Subjects will fast for at least 10 hours prior to administration of the study drugs and for four (4) hours after administration of the study drugs during each study period. Standardized meals will be provided in each study period. Water will not be accessible to the subjects 1 hour to administration of the study drugs and 2 hours after administration of the study drugs in each period. A total of 20 blood samples will be withdrawn for pharmacokinetic profiling during each study period. The plasma concentrations of R- and S-enantiomers of ibuprofen will be measured by a validated LC-MS/MS analytical method. ANOVA will be performed on log transformed pharmacokinetic parameters Cmax, AUC0-t and 90% confidence interval will be constructed for the ratio of geometric least square mean of the Test and Reference products, obtained from the log-transformed data. Bioequivalence will be concluded if the ratio estimate as well as its 90% confidence interval of S-enantiomers of ibuprofen, both falls within the acceptable range of 80.00% to 125.00% for Cmax, AUC0-t.
- Conditions
- Healthy
- Being tested
- Ibuprofen D, Nurofen® for Children
- Keywords
- Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen DDrug
Ibuprofen D, oral suspension, 200 mg / 5ml, manufactured by LLC Pharmtechnology, Belarus
Nurofen® for ChildrenDrug
Nurofen® for Children, Oral Suspension, 100 mg / 5 ml, marketed by Reckitt Benckiser Healthcare International Ltd, UK
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen D, oral suspension | Experimental | Ibuprofen oral suspension, 200 mg/ 5 ml is the test product. In period 1 and period 2, 15 of 30 subjects will be given single oral dose (5 ml containing 200 mg of ibuprofen) of suspension. Receives: Drug: Ibuprofen D |
| Nurofen® for Children, oral suspension | Active comparator | Nurofen® for Children oral suspension, 100 mg/ 5 ml is the reference product. In period 1 and period 2, 15 of 30 subjects will be given single oral dose (10 ml containing 200 mg of ibuprofen) of suspension. Receives: Drug: Nurofen® for Children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary pharmacokinetic parameter for S-enantiomer of ibuprofen
Peak Plasma Concentration (Cmax)
Measured: 8 days
Primary pharmacokinetic parameter for S-enantiomer of ibuprofen
Area under the plasma concentration versus time curve from time 0 to the last measured concentration (AUC0-t)
Measured: 8 days
Secondary outcomes (6)
Safety and tolerability of the investigational products (testing and reference)
Number of adverse events, number of deaths, number of severe adverse events in subjects who have taken at least one dose of investigational products.
Measured: 22 days
Secondary pharmacokinetic parameter for S-enantiomer of ibuprofen
Area under the plasma concentration versus time curve from time 0 to to infinite time(AUC0-∞)
Measured: 8 days
Secondary pharmacokinetic parameter for S-enantiomer of ibuprofen
Time of maximum measured plasma concentration (Tmax)
Measured: 8 days
Secondary pharmacokinetic parameter for S-enantiomer of ibuprofen
Elimination or terminal half-life (T1/2)
Measured: 8 days
Secondary pharmacokinetic parameter for S-enantiomer of ibuprofen
Elimination rate constant (Kel)
Measured: 8 days
Secondary pharmacokinetic parameter for S-enantiomer of ibuprofen
Residual area (AUCresid)
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start11 Jun 2018
- Primary completion24 Jun 2018
- Study completion25 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmtechnology LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ClinPharmInvest, LLC
- Responsible party
- Sponsor
- Investigators
- Alexander Khokhlov, Professor, Principal investigator, ClinPharmInvest, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561558
- Sponsor's protocol ID
- FRM-03-IBU/21/11/17
- Status last verified
- Jun 2018
- First submitted
- 7 Jun 2018
- Last updated
- 1 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The Company may provide the individual participant data after privacy protection on case by case basis.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Randomized, Cross-over, Two Period, Two-sequence, One-center, Bioequivalence Study of Ibuprofen D, Oral Suspension, 200 mg / 5ml (Pharmtechnology, Belarus) and Nurofen® for Children, Oral Suspension 100 mg / 5 ml (Reckitt Benckiser Healthcare International Ltd, UK) in Healthy Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT03561558
- Acronym / sponsor ID
- FRM-03-IBU/21/11/17
- Conditions
- Healthy
- Keywords
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pharmtechnology LLCIndustry (pharma, biotech, devices)
- Collaborators
- ClinPharmInvest, LLC
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 24 Jun 2018 (actual)
- Study completion
- 25 Jun 2018 (actual)
- First posted
- 19 Jun 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.
To demonstrate bioequivalence of single dose test formulation of Ibuprofen,oral suspension 200 mg/5 ml (containing ibuprofen 200 mg) of Pharmtechnology LLC, Republic of Belarus with reference Nurofen® for Children, oral suspension 100 mg / 5 ml (containing ibuprofen 100 mg) of "Reckitt Benckiser Healthcare International Ltd, .", UK in normal, healthy, adult, human subjects under fasting conditions.To monitor adverse events and ensure the safety
Detailed description
Total 30 normal healthy adult subjects will be enrolled in the study. Subjects will be administered either the Test (5 ml of oral suspension containing 200 mg of ibuprofen) or the Reference Product (10ml of oral suspension containing 200 mg of ibuprofen) with 200 mL of water in each period as per the randomization schedule. Subjects will fast for at least 10 hours prior to administration of the study drugs and for four (4) hours after administration of the study drugs during each study period. Standardized meals will be provided in each study period. Water will not be accessible to the subjects 1 hour to administration of the study drugs and 2 hours after administration of the study drugs in each period. A total of 20 blood samples will be withdrawn for pharmacokinetic profiling during each study period. The plasma concentrations of R- and S-enantiomers of ibuprofen will be measured by a validated LC-MS/MS analytical method. ANOVA will be performed on log transformed pharmacokinetic parameters Cmax, AUC0-t and 90% confidence interval will be constructed for the ratio of geometric least square mean of the Test and Reference products, obtained from the log-transformed data. Bioequivalence will be concluded if the ratio estimate as well as its 90% confidence interval of S-enantiomers of ibuprofen, both falls within the acceptable range of 80.00% to 125.00% for Cmax, AUC0-t.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen D, oral suspension | Experimental | Drug: Ibuprofen DIbuprofen oral suspension, 200 mg/ 5 ml is the test product. In period 1 and period 2, 15 of 30 subjects will be given single oral dose (5 ml containing 200 mg of ibuprofen) of suspension. |
| Nurofen® for Children, oral suspension | Active comparator | Drug: Nurofen® for ChildrenNurofen® for Children oral suspension, 100 mg/ 5 ml is the reference product. In period 1 and period 2, 15 of 30 subjects will be given single oral dose (10 ml containing 200 mg of ibuprofen) of suspension. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy adult human subjects, aged between 18 to 45 years.
- Subjects with Body Mass Index (BMI) 18.5 to 30 kg/m2.
- Female subjects with a negative pregnancy test.
- Non-lactating females.
- If subject is a female and is of child bearing potential, she should be practicing an acceptable non-hormonal method of birth control for the duration of the study(at least 14 days before the start of the study, throughout the study and 14 days after the completion of the study), such as a combination of male condom and diaphragm with spermicide.
Key exclusion criteria (31 listed)
- Subjects with a known history of allergic disorders.
- Subjects with a known history of drug hypersensitivity to ibuprofen d or any excipients of the formulation.
- Subjects with a known history of drug intolerance.
- Subjects with history of psychiatric disorders.
- Subjects with history of epilepsy, seizures, other neurological disorders.
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 DIbuprofen D, oral suspension, 200 mg / 5ml, manufactured by LLC Pharmtechnology, Belarus | Drug | Ibuprofen D, oral suspension |
| Nurofen® for ChildrenNurofen® for Children, Oral Suspension, 100 mg / 5 ml, marketed by Reckitt Benckiser Healthcare International Ltd, UK | Drug | Nurofen® for Children, oral suspension |
Primary outcome
Primary pharmacokinetic parameter for S-enantiomer of ibuprofen
Time frame: 8 days
Peak Plasma Concentration (Cmax)
Primary pharmacokinetic parameter for S-enantiomer of ibuprofen
Time frame: 8 days
Area under the plasma concentration versus time curve from time 0 to the last measured concentration (AUC0-t)
6 secondary outcomes
Safety and tolerability of the investigational products (testing and reference)
Time frame: 22 days
Secondary pharmacokinetic parameter for S-enantiomer of ibuprofen
Time frame: 8 days
Secondary pharmacokinetic parameter for S-enantiomer of ibuprofen
Time frame: 8 days
Secondary pharmacokinetic parameter for S-enantiomer of ibuprofen
Time frame: 8 days
Secondary pharmacokinetic parameter for S-enantiomer of ibuprofen
Time frame: 8 days
Secondary pharmacokinetic parameter for S-enantiomer of ibuprofen
Time frame: 8 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 1 Nov 2018.
- Individual participant dataSharing planned: Undecided. The Company may provide the individual participant data after privacy protection on case by case basis.
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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.
Alexander Khokhlov, Professor principal investigator
ClinPharmInvest, LLC
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 D and Nurofen® for Children in people with Healthy, run by Pharmtechnology LLC at 1 site in Russia.
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 8 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 1 Nov 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 Russia. 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?
Primary pharmacokinetic parameter for S-enantiomer of ibuprofen (time frame: 8 days). 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 1 Nov 2018.