Study identifier:D9584C00010
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
Bioequivalence, AUC, Cmax, Pharmacokinetics
Phase 1
Yes
Omeprazole
All
54
Interventional
18 Years - 50 Years
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verified 01 Nov 2014 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Active Comparator: Omeprazole 20mg aqueous Treatment A: a single oral dose of omeprazole 20-mg aqueous-solvent based capsules (AstraZeneca - test) | Drug: Omeprazole Omeprazole 20 mg (AstraZeneca - test) Omeprazole 40 mg (AstraZeneca - test) Omeprazole 20 (Merck - reference) Omeprazole 40mg (Merck - reference) Other Name: Prilosec |
Active Comparator: Omeprazole 20mg organic Treatment B: a single oral dose of omeprazole 20-mg organic-solvent based capsules (Merck – reference for Treatment A) | Drug: Omeprazole Omeprazole 20 mg (AstraZeneca - test) Omeprazole 40 mg (AstraZeneca - test) Omeprazole 20 (Merck - reference) Omeprazole 40mg (Merck - reference) Other Name: Prilosec |
Active Comparator: Omeprazole 40mg aqueous Treatment C: a single dose of omeprazole 40-mg aqueous-solvent based capsules (AstraZeneca - test) | Drug: Omeprazole Omeprazole 20 mg (AstraZeneca - test) Omeprazole 40 mg (AstraZeneca - test) Omeprazole 20 (Merck - reference) Omeprazole 40mg (Merck - reference) Other Name: Prilosec |
Active Comparator: Omeprazole 40mg organic Treatment D: a single dose of omeprazole 40-mg organic-solvent based capsules (Merck – reference for Treatment C) | Drug: Omeprazole Omeprazole 20 mg (AstraZeneca - test) Omeprazole 40 mg (AstraZeneca - test) Omeprazole 20 (Merck - reference) Omeprazole 40mg (Merck - reference) Other Name: Prilosec |