Status:
COMPLETED
Esomeprazole Bioavailability Study With 40 mg Oral Single Dose Fasted and Fed Administration
Lead Sponsor:
Mepha Ltd.
Collaborating Sponsors:
SocraTec R&D GmbH
SocraMetrics GmbH
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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 d...
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 Esomeprazol...
Eligibility Criteria
Inclusion
- Subject has to:
- be Caucasian male
- be aged between 18-55 years, inclusive
- have a body-mass index (BMI): ≥ 19 kg/m² and ≤ 27 kg/m²
- be considered to be healthy on the basis of extensive pre-study eligibility assessment
- be a non-smoker or an ex-smoker for at least 1 month
- be willing and capable to confirm written consent to enrolment after ample information has been provided
Exclusion
- 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.
- presence of active gastric/duodenal ulcer or gastrointestinal bleeding, of enteritis like Crohn's disease or ulcerative colitis, clinically confirmed coronary heart disease and/or cerebrovascular disease, cardiac insufficiency (NYHA II-IV), severe liver insufficiency, or severe renal insufficiency
- history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
- pathological ECG (12 standard leads)
- known allergic reactions to the active ingredient used, substituted benzimidazole or to other constituents of the pharmaceutical preparations
- subjects with severe allergies or multiple drug allergies
- positive results of the urine drug screen
- laboratory values out of normal range unless the deviation from normal is judged as not relevant for the study by the investigator
- positive anti-HIV-test, HBs-AG-test or anti-HCV-test
- lactose or fructose intolerance
- glucose-galactose malabsorption
- history of or current drug or alcohol dependence
- regular intake of alcoholic food or beverages of ≥ 40 g pure ethanol per day
- subjects who are on a diet which could affect the pharmacokinetics of the drug
- regular intake of caffeine containing food or beverages of ≥ 500 mg caffeine per day
- blood donation or other blood loss of more than 400 ml within the last two months prior to the start of the study
- participation in a clinical trial during the last two months prior to the start of the study
- subjects, who report a frequent occurrence of migraine attacks
- regular treatment with any systemically available medication (except hormonal replacement therapy e.g. L-thyroxine) within 14 days prior to the first administration of the study medication
- subjects suspected or known not to follow instructions
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00889850
Start Date
April 1 2009
End Date
June 1 2009
Last Update
June 23 2009
Active Locations (1)
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1
SocraTec R&D Probandenstation
Erfurt, Thuringia, Germany, 99084