Status:
COMPLETED
A Study to Evaluate the Effect on 24-hour, Intragastric pH of RAB ER 50-mg Capsules Compared With Esomeprazole (Nexium) 40 mg Capsules and Rabeprazole (Aciphex) 20-mg Tablets
Lead Sponsor:
Eisai Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This will be a randomized, open-label, single-center, 3-way crossover study in healthy subjects who are confirmed to be Helicobacter pylori (H. pylori)-negative. The study will consist of 3 study peri...
Eligibility Criteria
Inclusion
- Key inclusion:
- Healthy male and female subjects, including women of child-bearing potential, aged 18 to 55 years, inclusive
- Subjects who are able to tolerate the insertion and placement of a pH probe on 2 occasions per study period (Day -1 and Day 5)
- Key Exclusion:
- Subjects who are H. pylori-positive
- Subjects who have a history of any gastrointestinal disorder or surgery likely to influence drug absorption (e.g., history of gastric resection)
- Known hypersensitivity to rabeprazole, esomeprazole, or related compounds or any ingredient in the formulations
- Other standard clinical pharmacology exclusion criteria for healthy volunteers
Exclusion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01153659
Start Date
July 1 2010
End Date
October 1 2010
Last Update
November 1 2013
Active Locations (1)
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1
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States, 73104