Study to Investigate the Relative Bioavailability of Ibuprofen in Healthy Volunteers

NCT ID: NCT02183012

Last Updated: 2014-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-08-31

Brief 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

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A: Ibuprofen extrudate, fed state

Group Type: EXPERIMENTAL

Ibuprofen extrudate

Intervention Type: DRUG

B: Ibuprofen extrudate, fasted state

Group Type: EXPERIMENTAL

Ibuprofen extrudate

Intervention Type: DRUG

C: Ibuprofen lysinate tablet, fed state

Group Type: ACTIVE_COMPARATOR

Ibuprofen lysinate

Intervention Type: DRUG

D: Ibuprofen lysinate tablet, fasted state

Group Type: ACTIVE_COMPARATOR

Ibuprofen lysinate

Intervention Type: DRUG

E: Ibuprofen tablet, fed state

Group Type: ACTIVE_COMPARATOR

Ibuprofen

Intervention Type: DRUG

F: Ibuprofen tablet, fasted state

Group Type: ACTIVE_COMPARATOR

Ibuprofen

Intervention Type: DRUG

Interventions

Ibuprofen extrudate

Intervention Type: DRUG

Ibuprofen lysinate

Intervention Type: DRUG

Ibuprofen

Intervention Type: DRUG

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1024.5

Identifier Type: -

Identifier Source: org_study_id