NCT00889850

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

Open, Randomised, Single-Dose, 2x2-Way Cross-Over Comparative Oral Bioavailability Study in Healthy Adult Male Subjects Under Fasted Conditions (Block I) and Under Fed Conditions (Block II); Comparison of 40 mg Esomeprazole Mepha Capsules (Test) With 40 mg Esomeprazole INexium MUPS Tablets (Reference)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Mepha Ltd. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

* The primary objective of the single dose fasted part of the study is to compare the rate and extent of absorption of esomeprazole from 40 mg Esomeprazole Mepha capsules (Test) with 40 mg Esomeprazole INexium MUPS tablets (Reference) after single dose administration under fasted conditions, determined by use of AUC0-tlast and Cmax obtained from esomeprazole plasma concentrations. * The primary objective of the single dose fed in combination with the fasted part of the study is to compare the maximum concentration of esomeprazole determined after 40 mg Esomeprazole Mepha capsules (Test) single dose administration under fed conditions in comparison with 40 mg Esomeprazole INexium MUPS tablets (Reference) after single dose administration under fasted and fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland)	40 mg esomeprazole, single dose administration under fasted and fed condition
DRUG	INexium 40 mg MUPS tablets (AstraZeneca, France)	40 mg esomeprazole, oral single dose administration under fasted and fed condition

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2009-04-29
• Last updated: 2009-06-23

Locations

1 site across 1 country: Germany