Prilosec Bioequivalence Study in Healthy Volunteers

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is An Open-label, Randomized, Single-center, 4-way Crossover, Single dose Bioequivalence Study Comparing Omeprazole 20 and 40-mg Aqueous solvent Based Capsules Manufactured by AstraZeneca with Omeprazole 20 and 40-mg Organic-solvent Based Capsules Manufactured by Merck

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Treatments: Omeprazole

Criteria

Inclusion Criteria:

• Healthy male and female volunteers aged 18 to 50 years, inclusive, with suitable veins for cannulation or repeated venepuncture.

• Female could be of nonchildbearing potential (postmenopausal or irreversible surgical sterilization) and childbearing potential (negative pregnancy test at screening and use 2 effective methods of avoiding pregnancy).

• Have a body mass index (BMI) between 18 and 30 kg/m2, inclusive, and a weight of at least 50 kg and no more than 100 kg, inclusive.

Exclusion Criteria:

• History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study.

• History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.

• Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational medicinal product (IMP).

• Any clinically significant abnormalities in the physical examination, clinical laboratory values, 12-lead ECG, or vital signs, as judged by the Investigator.

• Moderate to heavy smokers (more than 10 cigarettes per day or equivalent in tobacco-containing products).