Status:
COMPLETED
Fed Study of Rabeprazole Sodium Tablets 20 mg and Aciphex® Tablets 20 mg
Lead Sponsor:
Mylan Pharmaceuticals Inc
Conditions:
Healthy
Eligibility:
All Genders
8+ years
Phase:
PHASE1
Brief Summary
The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole sodium 20 mg tablets to Eisai's Aciphex® 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administ...
Eligibility Criteria
Inclusion
- healthy, adult subjects, 18 years and older
- able to swallow medication
Exclusion
- institutionalized subjects
- history of any significant disease
- use of any prescription or OTC medications within 14 days of start of study
- received any investigational products within 30 days prior to start of study
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2003
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00649493
Start Date
May 1 2003
End Date
June 1 2003
Last Update
April 23 2024
Active Locations (1)
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1
PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58104