Esomeprazole Bioavailability Study With 40 mg Oral Single Dose Fasted and Fed Administration

Phase 1 Completed 100 enrolled Mepha Ltd. SocraMetrics GmbH · collab SocraTec R&D GmbH · collab

RandomizedCrossoverOpen-label

Summary

The present study will be conducted in order to compare the bioavailability of 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland) and of INexium 40 mg MUPS tablets (AstraZeneca, France) under single dose fasted and fed conditions. The study will be conducted as a combined single dose study under fasted and fed conditions in a 2x2-period cross-over design with a wash out phase of at least 6 treatment-free days between administrations.

Timeline

Start: 2009-04
Primary completion: 2009-06
Completion: 2009-06

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Esomeprazole	Small molecule	40 mg	Oral

Indications

No indication recorded.