A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (Study CL2008-02)(P07814)(COMPLETED)

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Open-label randomized crossover design study. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Collaborators: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Omeprazole; Omeprazole, sodium bicarbonate drug combination

Criteria

Inclusion Criteria:

• Normal subjects who are 18-65 years of age.

• Non-childbearing potential females or those using birth control.

Exclusion Criteria:

• History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump inhibitors

• History of significant gastrointestinal disease

• Any significant medical illness

• Gastrointestinal disorder or surgery leading to impaired drug absorption

• Currently using gastrointestinal medications