Study to Investigate the Relative Bioavailability of Ibuprofen in Healthy Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Ibuprofen extrudate; Drug: Ibuprofen; Drug: Ibuprofen lysinate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02183012

1024.5

Details and patient eligibility

About

• 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.

Enrollment: 36 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 6 patient groups

A: Ibuprofen extrudate, fed state

Experimental group

Treatment:

Drug: Ibuprofen extrudate

B: Ibuprofen extrudate, fasted state

Experimental group

Treatment:

Drug: Ibuprofen extrudate

C: Ibuprofen lysinate tablet, fed state

Active Comparator group

Treatment:

Drug: Ibuprofen lysinate

D: Ibuprofen lysinate tablet, fasted state

Active Comparator group

Treatment:

Drug: Ibuprofen lysinate

E: Ibuprofen tablet, fed state

Active Comparator group

Treatment:

Drug: Ibuprofen

F: Ibuprofen tablet, fasted state

Active Comparator group

Treatment:

Drug: Ibuprofen