HealthyPhase 1NCT02183012
Study to Investigate the Relative Bioavailability of Ibuprofen in Healthy Volunteers
A Phase 1 study testing Ibuprofen extrudate, Ibuprofen lysinate and Ibuprofen in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to demonstrate average bioequivalence between a 400 mg ibuprofen extrudate tablet (Test) and a 400 mg ibuprofen lysinate tablet (Dolormin extra ®; reference 1) under fasted conditions. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ibuprofen extrudate, Ibuprofen lysinate and Ibuprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Aug 2002to Oct 2002
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females according to the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests:
- No finding deviating from normal and of clinical relevance
- No evidence of a clinically relevant concomitant disease.
- Age ≥ 21 and Age ≤ 50 years
- BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation
Who cannot join
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- History of recent surgery including dental surgery
- History of gastrointestinal ulcer or gastrointestinal inflammation (gastritis, ulcerative colitis, Crohn's disease)
- Blood dyscrasias of unknown origin
- Subjects with porphyries diseases
Show all 27Show fewer
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of allergy/hypersensitivity/allergic rhinitis (including drug allergy) which is deemed relevant to he trial as judged by the investigator
- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial except substitution therapy (thyroid, ovaries) and hormonal contraception
- Use of any drugs, which might influence the results of the trial (within 10 days prior to administration or during the trial)
- Participation in another trial with an investigational drug (within two months prior to administration or during the trial)
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 60 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range of clinical relevance
- Inability to comply with dietary regimen of study centre
- For female subjects:
- Pregnancy
- Positive pregnancy test
- No adequate contraception e.g. oral contraceptives, sterilisation, IUP (intrauterine pessary: in case a IUP was used for contraception, volunteers must be advised to employ additional contraceptive measures (e.g. condom by partner) because prostaglandin inhibition may alter IUP contraceptive efficacy)
- Inability to maintain this adequate contraception during the whole study period
- Lactation period
About this study
Official title: Open-label, Randomised, Single Dose, Four-way Crossover Study to Investigate the Relative Bioavailability of a 400 mg Ibuprofen Extrudate Tablet Compared to a 400 mg Ibuprofen Lysinate Tablet (Dolormin Extra®) and a 400 mg Ibuprofen Tablet (Brufen® 400 mg, Denmark) in Fasted Condition and After Ingestion of a Standardised Meal in Healthy Male and Female Volunteers.
- Study to demonstrate average bioequivalence between a 400 mg ibuprofen extrudate tablet (Test) and a 400 mg ibuprofen lysinate tablet (Dolormin extra ®; reference 1) under fasted conditions.
- Study to determine the relative bioavailability of ibuprofen following single administration of a 400 mg ibuprofen extrudate tablet (Test) compared to a 400 mg ibuprofen tablet (Brufen® 400mg, Denmark; Reference 2) under fasted conditions.
- Study to determine the relative bioavailability of ibuprofen following single administration of a 400 mg ibuprofen extrudate tablet (Test) compared to a 400 mg ibuprofen lysinate tablet (Dolormin extra ®; reference 1) or a 400 mg ibuprofen tablet (Brufen® 400mg, Denmark; Reference 2), respectively, under fed conditions.
- Study to evaluate the effect of food on the pharmacokinetics of ibuprofen for all three formulations.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen extrudateDrug
Ibuprofen lysinateDrug
IbuprofenDrug
| Study group | Role | What they receive |
|---|---|---|
| A: Ibuprofen extrudate, fed state | Experimental | Not described Receives: Drug: Ibuprofen extrudate |
| B: Ibuprofen extrudate, fasted state | Experimental | Not described Receives: Drug: Ibuprofen extrudate |
| C: Ibuprofen lysinate tablet, fed state | Active comparator | Not described Receives: Drug: Ibuprofen lysinate |
| D: Ibuprofen lysinate tablet, fasted state | Active comparator | Not described Receives: Drug: Ibuprofen lysinate |
| E: Ibuprofen tablet, fed state | Active comparator | Not described Receives: Drug: Ibuprofen |
| F: Ibuprofen tablet, fasted state | Active comparator | Not described Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞ (area under the concentration-time curve of the analyte in plasma from zero time to infinity)
Measured: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5
Cmax (maximum observed concentration of the analyte in plasma)
Measured: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5
AUC0-tz (area under the concentration-time curve of the analyte in plasma from zero time to the time of the last quantifiable drug concentration)
Measured: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5
Secondary outcomes (14)
Individual time courses of the ibuprofen plasma concentrations
Measured: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5
AUCtrunc (Area under the concentration-time curve of the analyte in plasma from zero time to median tmax values of the reference formulation)
Measured: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5
tmax (time to reach Cmax)
Measured: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5
t1/2 (terminal half-life of the analyte in plasma)
Measured: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5
λz (terminal rate constant of the analyte in plasma)
Measured: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5
MRTtot (total mean residence time of the analyte molecules in the body)
Measured: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5
CL/F (total clearance of the analyte in plasma following extravascular administration)
Measured: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5
Vz/F (apparent volume of distribution during the terminal phase λz following extravascular administration)
Measured: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5
Number of patients with adverse events
Measured: up to 24 days
Number of patients with abnormal changes in laboratory parameters
Measured: up to 8 days following last drug administration
Number of patients with clinically significant changes in vital signs (blood pressure (BP), pulse rate (PR))
Measured: up to 8 days following last drug administration
Number of patients with abnormal changes in 12-lead electrocardiogram (ECG)
Measured: up to 8 days following last drug administration
Number of patients with abnormal findings in physical examination
Measured: up to 8 days following last drug administration
Assessment of tolerability on a 4-point scale
Measured: up to 8 days following 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 startAug 2002
- Primary completionOct 2002
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
- 36 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
- NCT02183012
- Sponsor's protocol ID
- 1024.5
- Status last verified
- Jul 2014
- First submitted
- 4 Jul 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Randomised, Single Dose, Four-way Crossover Study to Investigate the Relative Bioavailability of a 400 mg Ibuprofen Extrudate Tablet Compared to a 400 mg Ibuprofen Lysinate Tablet (Dolormin Extra®) and a 400 mg Ibuprofen Tablet (Brufen® 400 mg, Denmark) in Fasted Condition and After Ingestion of a Standardised Meal in Healthy Male and Female Volunteers.
- ClinicalTrials.gov ID
- NCT02183012
- Acronym / sponsor ID
- 1024.5
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- Primary completion
- Oct 2002 (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.
- Study to demonstrate average bioequivalence between a 400 mg ibuprofen extrudate tablet (Test) and a 400 mg ibuprofen lysinate tablet (Dolormin extra ®; reference 1) under fasted conditions.
- Study to determine the relative bioavailability of ibuprofen following single administration of a 400 mg ibuprofen extrudate tablet (Test) compared to a 400 mg ibuprofen tablet (Brufen® 400mg, Denmark; Reference 2) under fasted conditions.
- Study to determine the relative bioavailability of ibuprofen following single administration of a 400 mg ibuprofen extrudate tablet (Test) compared to a 400 mg ibuprofen lysinate tablet (Dolormin extra ®; reference 1) or a 400 mg ibuprofen tablet (Brufen® 400mg, Denmark; Reference 2), respectively, under fed conditions.
- Study to evaluate the effect of food on the pharmacokinetics of ibuprofen for all three formulations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A: Ibuprofen extrudate, fed state | Experimental | Drug: Ibuprofen extrudate |
| B: Ibuprofen extrudate, fasted state | Experimental | Drug: Ibuprofen extrudate |
| C: Ibuprofen lysinate tablet, fed state | Active comparator | Drug: Ibuprofen lysinate |
| D: Ibuprofen lysinate tablet, fasted state | Active comparator | Drug: Ibuprofen lysinate |
| E: Ibuprofen tablet, fed state | Active comparator | Drug: Ibuprofen |
| F: Ibuprofen tablet, fasted state | Active comparator | Drug: Ibuprofen |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy males and females according to the following criteria:
- Age ≥ 21 and Age ≤ 50 years
- BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation
Key exclusion criteria (27 listed)
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- History of recent surgery including dental surgery
- History of gastrointestinal ulcer or gastrointestinal inflammation (gastritis, ulcerative colitis, Crohn's disease)
- Blood dyscrasias of unknown origin
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 extrudate | Drug | A: Ibuprofen extrudate, fed state, B: Ibuprofen extrudate, fasted state |
| Ibuprofen lysinate | Drug | C: Ibuprofen lysinate tablet, fed state, D: Ibuprofen lysinate tablet, fasted state |
| Ibuprofen | Drug | E: Ibuprofen tablet, fed state, F: Ibuprofen tablet, fasted state |
Primary outcome
AUC0-∞ (area under the concentration-time curve of the analyte in plasma from zero time to infinity)
Time frame: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5
Cmax (maximum observed concentration of the analyte in plasma)
Time frame: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5
AUC0-tz (area under the concentration-time curve of the analyte in plasma from zero time to the time of the last quantifiable drug concentration)
Time frame: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5
14 secondary outcomes
Individual time courses of the ibuprofen plasma concentrations
Time frame: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5
AUCtrunc (Area under the concentration-time curve of the analyte in plasma from zero time to median tmax values of the reference formulation)
Time frame: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5
tmax (time to reach Cmax)
Time frame: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5
t1/2 (terminal half-life of the analyte in plasma)
Time frame: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5
λz (terminal rate constant of the analyte in plasma)
Time frame: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5
MRTtot (total mean residence time of the analyte molecules in the body)
Time frame: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5
CL/F (total clearance of the analyte in plasma following extravascular administration)
Time frame: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5
Vz/F (apparent volume of distribution during the terminal phase λz following extravascular administration)
Time frame: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5
Number of patients with adverse events
Time frame: up to 24 days
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 8 days following last drug administration
Number of patients with clinically significant changes in vital signs (blood pressure (BP), pulse rate (PR))
Time frame: up to 8 days following last drug administration
Number of patients with abnormal changes in 12-lead electrocardiogram (ECG)
Time frame: up to 8 days following last drug administration
Number of patients with abnormal findings in physical examination
Time frame: up to 8 days following last drug administration
Assessment of tolerability on a 4-point scale
Time frame: up to 8 days following 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 8 Jul 2014.
- 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 extrudate, Ibuprofen lysinate and Ibuprofen 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 7 inclusion and 27 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 8 Jul 2014. 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?
AUC0-∞ (area under the concentration-time curve of the analyte in plasma from zero time to infinity) (time frame: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5). The study lists 3 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 8 Jul 2014; AzTrials last refreshed its copy on 8 Nov 2026.