Esomeprazole Bioavailability Study With 40 mg Oral Single Dose Fasted and Fed Administration

This study has been completed.
Sponsor:
Collaborators:
SocraTec R&D GmbH
SocraMetrics GmbH
Information provided by:
Mepha Ltd.
ClinicalTrials.gov Identifier:
NCT00889850
First received: April 28, 2009
Last updated: June 22, 2009
Last verified: June 2009
  Purpose

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
Healthy
Drug: 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland)
Drug: INexium 40 mg MUPS tablets (AstraZeneca, France)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
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)

Resource links provided by NLM:


Further study details as provided by Mepha Ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Descriptive characterisation of safety and tolerability of the investigational products in the study population. [ Time Frame: April - June 2009 ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: April 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Oral fasted administration of one capsule of 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland)
Drug: 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland)
40 mg esomeprazole, single dose administration under fasted and fed condition
Other Name: Test
Active Comparator: 2
Oral fasted administration of one tablet of INexium 40 mg MUPS tablets (AstraZeneca, France)
Drug: INexium 40 mg MUPS tablets (AstraZeneca, France)
40 mg esomeprazole, oral single dose administration under fasted and fed condition
Other Name: Reference
Active Comparator: 3
Oral fed administration of one capsule of 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland)
Drug: 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland)
40 mg esomeprazole, single dose administration under fasted and fed condition
Other Name: Test
Active Comparator: 4
Oral fed administration of one tablet of INexium 40 mg MUPS tablets (AstraZeneca, France)
Drug: INexium 40 mg MUPS tablets (AstraZeneca, France)
40 mg esomeprazole, oral single dose administration under fasted and fed condition
Other Name: Reference

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.
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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 exclusion criteria:

    1. 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.
    2. 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
    3. history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
    4. pathological ECG (12 standard leads)
    5. known allergic reactions to the active ingredient used, substituted benzimidazole or to other constituents of the pharmaceutical preparations
    6. subjects with severe allergies or multiple drug allergies
    7. positive results of the urine drug screen
    8. laboratory values out of normal range unless the deviation from normal is judged as not relevant for the study by the investigator
    9. positive anti-HIV-test, HBs-AG-test or anti-HCV-test
    10. lactose or fructose intolerance
    11. glucose-galactose malabsorption
    12. history of or current drug or alcohol dependence
    13. regular intake of alcoholic food or beverages of ≥ 40 g pure ethanol per day
    14. subjects who are on a diet which could affect the pharmacokinetics of the drug
    15. regular intake of caffeine containing food or beverages of ≥ 500 mg caffeine per day
    16. blood donation or other blood loss of more than 400 ml within the last two months prior to the start of the study
    17. participation in a clinical trial during the last two months prior to the start of the study
    18. subjects, who report a frequent occurrence of migraine attacks
    19. 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
    20. subjects suspected or known not to follow instructions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00889850

Locations
Germany
SocraTec R&D Probandenstation
Erfurt, Thüringen, Germany, 99084
Sponsors and Collaborators
Mepha Ltd.
SocraTec R&D GmbH
SocraMetrics GmbH
Investigators
Principal Investigator: Frank Donath, MD SocraTec R&D GmbH
  More Information

No publications provided

Responsible Party: Sabine Galliker, Mepha
ClinicalTrials.gov Identifier: NCT00889850     History of Changes
Other Study ID Numbers: ESO 001.2009, SocraTec: 1216es09ct, EudraCT: 2009-010941-29
Study First Received: April 28, 2009
Last Updated: June 22, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Mepha Ltd.:
Healthy
Bioavailability
Bioequivalence
Esomeprazole
Bioavailability, Therapeutical Indication Not Studied

Additional relevant MeSH terms:
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014