Ibuprofen Bioavailability Trial With Oral Single Dose Administration.
Status:
Completed
Trial end date:
2016-10-01
Target enrollment:
Participant gender:
Summary
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.