Overview

A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED)

Status:
Completed
Trial end date:
2008-06-01
Target enrollment:
0
Participant gender:
All
Summary
Open-label randomized crossover design studies. 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. The other 30 participants will receive a single administration of sodium bicarbonate.
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