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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00889850

Enrollment

100

Registered

2009-04-29

Start date

2009-04-30

Completion date

2009-06-30

Last updated

2009-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy, Bioavailability, Bioequivalence, Esomeprazole, Bioavailability, Therapeutical Indication Not Studied

Brief 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.

Interventions

DRUG40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland)

40 mg esomeprazole, single dose administration under fasted and fed condition

DRUGINexium 40 mg MUPS tablets (AstraZeneca, France)

40 mg esomeprazole, oral single dose administration under fasted and fed condition

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Subject has to: 1. be Caucasian male 2. be aged between 18-55 years, inclusive 3. have a body-mass index (BMI): ≥ 19 kg/m² and ≤ 27 kg/m² 4. be considered to be healthy on the basis of extensive pre-study eligibility assessment 5. be a non-smoker or an ex-smoker for at least 1 month 6. be willing and capable to confirm written consent to enrolment after ample information has been provided

Exclusion criteria

* Subjects cannot be included if they match any of the following

Design outcomes

Primary

Measure	Time frame
Comparison of pharmacokinetic parameters of esomeprazole after single oral doses of Esomeprazole Mepha capsules (Test) and 40 mg Esomeprazole INexium MUPS tablets (Reference) under fasted and fed conditions.	April - June 2009

Secondary

Measure	Time frame
Descriptive characterisation of safety and tolerability of the investigational products in the study population.	April - June 2009

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026