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

NCT00889850 | Completed Phase 1

• 3 other identifiers: ESO 001.2009SocraTec: 1216es09ctEudraCT: 2009-010941-29
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Healthy; Bioavailability; Bioequivalence; Esomeprazole; Bioavailability, Therapeutical Indication Not Studied

Outcome Measures

Primary Outcomes (1)

• 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.

  April - June 2009

Secondary Outcomes (1)

• Descriptive characterisation of safety and tolerability of the investigational products in the study population.

  April - June 2009

Study Arms (4)

1

ACTIVE COMPARATOR

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

Drug: 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland)

2

ACTIVE COMPARATOR

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

Drug: INexium 40 mg MUPS tablets (AstraZeneca, France)

3

ACTIVE COMPARATOR

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

Drug: 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland)

4

ACTIVE COMPARATOR

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

Drug: INexium 40 mg MUPS tablets (AstraZeneca, France)

Interventions

40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland) DRUG

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

Also known as: Test

1; 3

INexium 40 mg MUPS tablets (AstraZeneca, France) DRUG

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

Also known as: Reference

2; 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mepha Ltd.: lead
• SocraTec R&D GmbH: collaborator
• SocraMetrics GmbH: collaborator

Study Sites (1)

SocraTec R&D Probandenstation

Erfurt, Thuringia, 99084, Germany

Location

MeSH Terms

Interventions

major urinary proteins

Study Officials

• Frank Donath, MD

  SocraTec R&D GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 28, 2009
• First Posted: April 29, 2009
• Study Start: April 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: June 23, 2009

Record last verified: 2009-06

Locations

DE (1)