Prilosec Bioequivalence Study in healthy volunteers

Study identifier:D9584C00010

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Bioequivalence, AUC, Cmax, Pharmacokinetics

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Omeprazole

Sex

All

Actual Enrollment

54

Study type

Interventional

Age

18 Years - 50 Years

Date

Study Start Date: 01 Aug 2013
Primary Completion Date: 01 Nov 2013
Study Completion Date: 01 Nov 2013

Study design

Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Nov 2014 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria