NCT01921920

Prilosec Bioequivalence Study in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Conditions

• Bioequivalence, AUC, Cmax, Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Omeprazole	Omeprazole 20 mg (AstraZeneca - test) Omeprazole 40 mg (AstraZeneca - test) Omeprazole 20 (Merck - reference) Omeprazole 40mg (Merck - reference)

Timeline

• Start date: 2013-08-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2013-08-14
• Last updated: 2013-11-25

Locations

1 site across 1 country: United States