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.
* 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
100
40 mg esomeprazole, single dose administration under fasted and fed condition
40 mg esomeprazole, oral single dose administration under fasted and fed condition
SocraTec R&D Probandenstation
Erfurt, Thuringia, Germany
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.
Time frame: April - June 2009
Descriptive characterisation of safety and tolerability of the investigational products in the study population.
Time frame: April - June 2009
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