Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis
Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to compare the blood drug levels of two prescribed medications,
immediate-release omeprazole 40 mg powder and delayed-release omeprazole 40 mg capsule to
determine which drug is better absorbed in patients with a slow stomach emptying
(gastroparesis). Delayed-release omeprazole has a protective coating to prevent the drug
omeprazole from being neutralized by stomach acid. Immediate-release omeprazole has sodium
bicarbonate (antacid) which neutralizes the stomach acid, eliminating the need for a
protective coating. Immediate-release omeprazole suspension may have a more rapid
pharmacokinetic profile and greater overall drug absorption in gastroparesis.
Phase:
Phase 4
Details
Lead Sponsor:
University of Louisville
Collaborators:
Bausch Health Americas, Inc. Valeant Pharmaceuticals International, Inc.