Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (COMPLETED)

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Omeprazole; Omeprazole, sodium bicarbonate drug combination

Criteria

Inclusion Criteria:

• Male or non-lactating, non-pregnant female subjects who are 18-65 years of age.

• Physical examination findings within normal limits for age.

Exclusion Criteria:

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

• History of peptic ulcer disease or other acid related gastrointestinal symptoms or heartburn with a frequency of more than one/month.

• Participation in any study of an investigational treatment in the 30 Days before Screening or participation in another study at any time during the period of this study

• Any significant medical illness that would contraindicate participation in the study

• Gastrointestinal disorder or surgery leading to impaired drug absorption

• Any abnormal Screening laboratory value that is clinically significant in the investigator's opinion

• Current use of any prescription or OTC medications that affect gastrointestinal function.

• Currently using or having a history of frequent use of antacids, OTC or prescription (Rx) histamine-2 (H2) receptor antagonists, or OTC or Rx use of proton pump inhibitors.