Ibuprofen Bioavailability Trial With Oral Single Dose Administration.

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.

Timeline

Start

2016-09

Primary completion

2016-10

Completion

2016-10

Drugs

Indications

No indication recorded.