Bioequivalence Clinical Trial
Official title:
Characterisation of Relative Bioavailability of a Newly Developed Ibuprofen Oral Powder Formulation in Comparison With Two Marketed Reference Products in a Single Dose, 3-period-crossover Design Under Fasting Conditions; Controlled, Open-label, Randomised Study With Bioequivalence Assessment
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.
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.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
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