Status:
COMPLETED
A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (Study CL2008-02)(P07814)(COMPLETED)
Lead Sponsor:
Bayer
Collaborating Sponsors:
Bausch Health Americas, Inc.
Conditions:
Gastric Acid
Human Experimentation
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 eva...
Detailed Description
Enrolled participants were divided into 2 groups, with 30 participants in each group. Group 1: This group was randomized into a single-dose, 2-way crossover design. These participants received single...
Eligibility Criteria
Inclusion
- Normal subjects who are 18-65 years of age.
- Non-childbearing potential females or those using birth control.
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00765206
Start Date
May 1 2008
End Date
August 1 2008
Last Update
March 11 2015
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