Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (COMPLETED)
Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
Participant gender:
Summary
This randomized, crossover study is to evaluate the early effectiveness, defined as effect on
intragastric pH during the first 4 hours after dosing, of Zegerid, Prilosec over-the-counter
(OTC) Tablets, and placebo on the 4th day of treatment to inhibit acid secretion. Additional
purposes are to:
1. provide pharmacodynamic evidence comparing 24-hr inhibition of acid secretion on the
1st, 4th, and 11th days of dosing with each of the indicated treatments;
2. compare Zegerid and Prilosec OTC for achieving their steady-state effects for
controlling 24-hr gastric acidity at steady-state on the 4th and 11th day of dosing.
3. evaluate early effectiveness, defined as effect on intragastric pH during the first 4
hours after administration, of Zegerid, Prilosec OTC Tablets, and placebo on acid
inhibition at steady-state when administered on the 11th day of dosing.
Phase:
Phase 3
Details
Lead Sponsor:
Bayer
Treatments:
Omeprazole Omeprazole, sodium bicarbonate drug combination