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

NCT ID: NCT00889850

Last Updated: 2009-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2009-06-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

1

Oral fasted administration of one capsule of 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland)

Group Type: ACTIVE_COMPARATOR

40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland)

Intervention Type: DRUG

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

2

Oral fasted administration of one tablet of INexium 40 mg MUPS tablets (AstraZeneca, France)

Group Type: ACTIVE_COMPARATOR

INexium 40 mg MUPS tablets (AstraZeneca, France)

Intervention Type: DRUG

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

3

Oral fed administration of one capsule of 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland)

Group Type: ACTIVE_COMPARATOR

40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland)

Intervention Type: DRUG

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

4

Oral fed administration of one tablet of INexium 40 mg MUPS tablets (AstraZeneca, France)

Group Type: ACTIVE_COMPARATOR

INexium 40 mg MUPS tablets (AstraZeneca, France)

Intervention Type: DRUG

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

Interventions

40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland)

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

Intervention Type: DRUG

INexium 40 mg MUPS tablets (AstraZeneca, France)

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

Intervention Type: DRUG

Other Intervention Names

Test; Reference

Eligibility 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

SocraTec R&D GmbH

OTHER

Sponsor Role: collaborator

SocraMetrics GmbH

INDUSTRY

Sponsor Role: collaborator

Mepha Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Mepha

Principal Investigators

Frank Donath, MD

Role: PRINCIPAL_INVESTIGATOR

SocraTec R&D GmbH

Locations

SocraTec R&D Probandenstation

Erfurt, Thuringia, Germany

Countries

Germany

Other Identifiers

SocraTec: 1216es09ct

Identifier Type: -

Identifier Source: secondary_id

EudraCT: 2009-010941-29

Identifier Type: -

Identifier Source: secondary_id

ESO 001.2009

Identifier Type: -

Identifier Source: org_study_id