CompletedNCT02183012Updated Jul 8, 2014

Study to Investigate the Relative Bioavailability of Ibuprofen in Healthy Volunteers

A Phase 1 interventional study of Ibuprofen extrudate and Ibuprofen lysinate in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-08.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 36
Allocation: Randomized
Ages: 21 Years to 50 Years
Sex: All

Study 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.
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.

Conditions studied

Healthy

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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
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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 36 participants (actual)

Study arms

Experimental
A: Ibuprofen extrudate, fed state
Drug: Ibuprofen extrudate
Experimental
B: Ibuprofen extrudate, fasted state
Drug: Ibuprofen extrudate
Active comparator
C: Ibuprofen lysinate tablet, fed state
Drug: Ibuprofen lysinate
Active comparator
D: Ibuprofen lysinate tablet, fasted state
Drug: Ibuprofen lysinate
Active comparator
E: Ibuprofen tablet, fed state
Drug: Ibuprofen
Active comparator
F: Ibuprofen tablet, fasted state
Drug: Ibuprofen

Interventions

DrugIbuprofen extrudate
DrugIbuprofen lysinate
DrugIbuprofen

What researchers measure

Primary outcomes

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

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

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 8, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02183012
Lead sponsor: Boehringer Ingelheim
Responsible party: Sponsor
First posted: Jul 8, 2014
Start date: Aug 2002
Primary completion: Oct 2002
Last update: Jul 8, 2014

View the source record on ClinicalTrials.gov ↗

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