Completed PHASE1 INTERVENTIONAL 4-arm 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)

Sponsor: Mepha Ltd.

Conditions Healthy

Interventions 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland) INexium 40 mg MUPS tablets (AstraZeneca, France)

Updated 5 times since 2017 Last updated: Jun 22, 2009 Started: Apr 30, 2009 Primary completion: Jun 30, 2009 Completion: Jun 30, 2009

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00889850, this PHASE1 trial focuses on Healthy and remains completed. Sponsored by Mepha Ltd., it has been updated 5 times since 2009, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Jan 2017 — Jun 2018 [monthly]

Completed PHASE1

First recorded

Apr 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Mepha Ltd.
SocraMetrics GmbH
SocraTec R&D GmbH

Data source: Mepha Ltd.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Erfurt, Germany