Ibuprofen Bioavailability Trial With Oral Single Dose Administration.

SocraTec R&D

Status and phase

Completed

Phase 1

Conditions

Bioequivalence

Treatments

Drug: Ibuprofen 400 mg soft capsule

Drug: Ibuprofen 400 mg film-coated tablet

Drug: Ibuprofen 400 mg oral powder

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03018015

1325ib16ct

Details and patient eligibility

About

The present study will be conducted in order to assess bioequivalence of the Test product (Ibuprofen 400 mg oral powder) and the Reference product 1 (Brufen 400 mg film-coated tablet), an approved market product in the European Union. Testing for bioequivalence will be performed considering AUC0-tlast and Cmax obtained after oral single dose fasted administration of ibuprofen.

In addition to the conventional immediate release tablet used as Reference 1, a soft capsule formulation will be applied as Reference 2 (Spalt Forte 400 mg Weichkapseln), as an example for a product with a very fast absorption rate.

All 3 immediate release preparations contain 400 mg ibuprofen.

Full description

The clinical trial will be performed in a single centre, open-label, randomised (order of treatments), balanced, 3-period, 6-sequence, single dose change-over design with administration under fasting conditions separated by a washout period of at least 2 treatment-free days.

Blood sample collection will be performed over 16 h after administration. This time is considered adequate to characterise plasma concentration vs. time profiles long enough for reliable estimation of the extent of absorption, i.e. the AUC derived from measurements is expected to cover at least 80 % of the AUC extrapolated to infinity.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

sex: male/female
ethnic origin: Caucasian
age: 18 years or older
body-mass index (BMI): ≥ 18.5 kg/m² and ≤ 30.0 kg/m², body weight > 40 kg
good state of health
non-smoker or ex-smoker for at least 3 months
written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in the clinical trial

Exclusion criteria

existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient
existing gastrointestinal diseases or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
history of gastrointestinal bleeding or perforation, related to previous NSAID therapy
existing, or history of, recurrent gastrointestinal ulcer/ bleeding
conditions involving an increased tendency to bleeding
active or known inflammatory bowel diseases (e.g. colitis ulcerosa, Crohn´s disease)
history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations
history of hypersensitivity reactions (e.g. bronchial spasm, asthma, rhinitis, urticaria, or angioedema) after intake of acetylsalicylic acid or other NSAIDs
subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
existing, or history of, bronchial asthma, chronic rhinitis or allergic diseases unless it is judged as not relevant for the clinical trial by the investigator
subjects with hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption
systolic blood pressure < 90 or > 145 mmHg
diastolic blood pressure < 60 or >90 mmHg
heart rate < 50 bpm or > 90 bpm
laboratory values out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the investigator except parameters ASAT, ALAT, bilirubin and creatinine (see exclusion criterion No. 18)
laboratory values: ASAT > 20 % ULN, ALAT > 10 % ULN, bilirubin > 20 % ULN and creatinine > 9 μmol/l ULN
positive anti-HIV-test (if positive to be verified by western blot), HBs-AG-test (if positive to be verified by test for HBc-IgM) or anti-HCVtest
acute or chronic diseases which may interfere with the pharmacokinetics of the IMP
history of or current drug or alcohol dependence
positive alcohol or drug test at screening examination
regular intake of alcoholic food or beverages of ≥ 40 g pure ethanol for male or ≥ 20 g pure ethanol for female per day
subjects who are on a diet which could affect the pharmacokinetics of the active ingredient
regular intake of caffeine containing food or beverages of ≥ 500 mg caffeine per day
blood donation or other blood loss of more than 400 ml within the last 2 months prior to individual enrolment of the subject
administration of any investigational medicinal product during the last 2 months prior to individual enrolment of the subject
regular treatment with any systemically available medication (except hormonal contraceptives)
subjects, who report a frequent occurrence of migraine attacks
positive pregnancy test at screening examination
pregnant or lactating women
female subjects who do not agree to apply highly effective contraceptive methods
subjects suspected or known not to follow instructions
subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial.