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

NCT00889850 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2009-06-23

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • SocraTec R&D GmbH

    collaborator OTHER

  • SocraMetrics GmbH

    collaborator INDUSTRY

  • Mepha Ltd.

    lead INDUSTRY

Principal Investigators

  • Frank Donath, MD · SocraTec R&D GmbH

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00889850 on ClinicalTrials.gov