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Sponsors and Collaborators: |
SocraTec R&D GmbH Mepha SocraMetrics GmbH |
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Information provided by: | SocraTec R&D GmbH |
ClinicalTrials.gov Identifier: | NCT00889850 |
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.
Condition | Intervention | Phase |
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Healthy |
Drug: 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland) Drug: INexium 40 mg MUPS tablets (AstraZeneca, France) |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Bio-availability Study |
Official Title: | 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) |
Enrollment: | 100 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Oral fasted administration of one capsule of 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland)
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Drug: 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland)
40 mg esomeprazole, single dose administration under fasted and fed condition
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2: Active Comparator
Oral fasted administration of one tablet of INexium 40 mg MUPS tablets (AstraZeneca, France)
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Drug: INexium 40 mg MUPS tablets (AstraZeneca, France)
40 mg esomeprazole, oral single dose administration under fasted and fed condition
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3: Active Comparator
Oral fed administration of one capsule of 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland)
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Drug: 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland)
40 mg esomeprazole, single dose administration under fasted and fed condition
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4: Active Comparator
Oral fed administration of one tablet of INexium 40 mg MUPS tablets (AstraZeneca, France)
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Drug: INexium 40 mg MUPS tablets (AstraZeneca, France)
40 mg esomeprazole, oral single dose administration under fasted and fed condition
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Subject has to:
Exclusion Criteria:
Subjects cannot be included if they match any of the following exclusion criteria:
existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the drug, i.e.
impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhoea or conditions associated with total or partial obstruction of the urinary tract.
Germany, Thüringen | |
SocraTec R&D Probandenstation | |
Erfurt, Thüringen, Germany, 99084 |
Principal Investigator: | Frank Donath, MD | SocraTec R&D GmbH |
Responsible Party: | SocraTec R&D GmbH ( Sylvia Grebe ) |
Study ID Numbers: | ESO 001.2009, SocraTec: 1216es09ct, EudraCT: 2009-010941-29 |
Study First Received: | April 28, 2009 |
Last Updated: | April 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00889850 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Healthy Bioavailability Bioequivalence Esomeprazole Bioavailability, Therapeutical Indication Not Studied |
Malnutrition Omeprazole Healthy |
Molecular Mechanisms of Pharmacological Action Therapeutic Uses Anti-Ulcer Agents Gastrointestinal Agents |
Omeprazole Enzyme Inhibitors Pharmacologic Actions |