HealthyPhase 1NCT02182960
Bioavailability of Ibuprofen Enantiomers Compared With Standard Brufen Sirup in Healthy Male Volunteers
A Phase 1 study testing Ibuprofen syrup and Brufen syrup in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Pharmacokinetics (relative bioavailability), safety and tolerability Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ibuprofen syrup and Brufen syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Sep 1998to Oct 1998
- 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 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males from 21 to 50 years and within +-20% of their normal weight (Broca index)
- Written informed consent
Who cannot join
- Any findings of the medical examination or laboratory tests deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory (especially bronchial asthma and chronic obstructive pulmonary disease), cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
Show all 16Show fewer
- Intake of a drug with a long half-life (>=24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study
- Use of any drugs which might influence the results of the trial within seven days prior to administration or during the trial
- Participation in another trial with an investigational drug within two months prior to the start of the study
- Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)
- Inability to refrain from smoking on study days
- Alcohol abuse
- Drug abuse
- Blood donation (>100 ml) within four weeks prior to administration
- Other disease or abnormality of clinical relevance
- Excessive physical activities within two weeks prior to administration or during the trial
About this study
Official title: An Open Two Way Cross Over Study to Relative Bioavailability of Ibuprofen Enantiomers After Single p.o. Administration of 200 mg Syrup (T) Compared With 200 mg Standard Brufen Sirup (R)
Pharmacokinetics (relative bioavailability), safety and tolerability
- Conditions
- Healthy
- Being tested
- Ibuprofen syrup, Brufen syrup
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen syrupDrug
Brufen syrupDrug
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Experimental | Not described Receives: Drug: Ibuprofen syrup |
| Brufen | Active comparator | Not described Receives: Drug: Brufen syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total area under the plasma drug concentration-time curve from time zero to infinity (AUC0-∞)
Measured: Up to 12 hours after each administration
Maximum drug plasma concentration (Cmax)
Measured: Up to 12 hours after each administration
Secondary outcomes (11)
Time to reach the maximum concentration of the analyte in plasma (tmax)
Measured: Up to 12 hours after each administration
Apparent terminal rate constant (λz)
Measured: Up to 12 hours after each administration
Apparent terminal half-life of the analyte in plasma (t1/2)
Measured: Up to 12 hours after each administration
Total area under the plasma drug concentration-time curve from time zero to the last quantifiable drug (AUC0-t(last))
Measured: Up to 12 hours after each administration
Mean residence time, total (MRTtot)
Measured: Up to 12 hours after each administration
Total plasma clearance divided by the systemic availability factor (CL/f)
Measured: Up to 12 hours after each administration
Volume of distribution during the terminal phase λz, divided by f (Vz/f)
Measured: Up to 12 hours after each administration
Number of adverse events
Measured: Up to 8 days after last drug administration
Change from baseline in 12-lead ECG (electrocardiogram)
Measured: Baseline, 8 days after last drug administration
Change in vital functions (blood pressure and puls rate)
Measured: Baseline, up to 8 days after last drug administration
Change from baseline in standard laboratory evaluation
Measured: Baseline, 8 days after last drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startSep 1998
- Primary completionOct 1998
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.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02182960
- Sponsor's protocol ID
- 1024.3
- Status last verified
- Aug 2018
- First submitted
- 4 Jul 2014
- Last updated
- 31 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Two Way Cross Over Study to Relative Bioavailability of Ibuprofen Enantiomers After Single p.o. Administration of 200 mg Syrup (T) Compared With 200 mg Standard Brufen Sirup (R)
- ClinicalTrials.gov ID
- NCT02182960
- Acronym / sponsor ID
- 1024.3
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 1998
- Primary completion
- Oct 1998 (actual)
- First posted
- 8 Jul 2014 (estimated)
- 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.
Pharmacokinetics (relative bioavailability), safety and tolerability
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | Experimental | Drug: Ibuprofen syrup |
| Brufen | Active comparator | Drug: Brufen syrup |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy males from 21 to 50 years and within +-20% of their normal weight (Broca index)
- Written informed consent
Key exclusion criteria (16 listed)
- Any findings of the medical examination or laboratory tests deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory (especially bronchial asthma and chronic obstructive pulmonary disease), cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
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 syrup | Drug | Ibuprofen |
| Brufen syrup | Drug | Brufen |
Primary outcome
Total area under the plasma drug concentration-time curve from time zero to infinity (AUC0-∞)
Time frame: Up to 12 hours after each administration
Maximum drug plasma concentration (Cmax)
Time frame: Up to 12 hours after each administration
11 secondary outcomes
Time to reach the maximum concentration of the analyte in plasma (tmax)
Time frame: Up to 12 hours after each administration
Apparent terminal rate constant (λz)
Time frame: Up to 12 hours after each administration
Apparent terminal half-life of the analyte in plasma (t1/2)
Time frame: Up to 12 hours after each administration
Total area under the plasma drug concentration-time curve from time zero to the last quantifiable drug (AUC0-t(last))
Time frame: Up to 12 hours after each administration
Mean residence time, total (MRTtot)
Time frame: Up to 12 hours after each administration
Total plasma clearance divided by the systemic availability factor (CL/f)
Time frame: Up to 12 hours after each administration
Volume of distribution during the terminal phase λz, divided by f (Vz/f)
Time frame: Up to 12 hours after each administration
Number of adverse events
Time frame: Up to 8 days after last drug administration
Change from baseline in 12-lead ECG (electrocardiogram)
Time frame: Baseline, 8 days after last drug administration
Change in vital functions (blood pressure and puls rate)
Time frame: Baseline, up to 8 days after last drug administration
Change from baseline in standard laboratory evaluation
Time frame: Baseline, 8 days after last drug administration
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 31 Aug 2018.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ibuprofen syrup and Brufen syrup in people with Healthy, run by Boehringer Ingelheim.
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 2 inclusion and 16 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 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Total area under the plasma drug concentration-time curve from time zero to infinity (AUC0-∞) (time frame: Up to 12 hours after each administration). 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 31 Aug 2018.