Status:
COMPLETED
Fasting Study of Alendronate Sodium Tablets (10 mg) and Fosamax Tablets (10 mg)
Lead Sponsor:
Mylan Pharmaceuticals Inc
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The objective of this study is to investigate the bioequivalence of Mylan's alendronate sodium 10 mg tablets to Merck's Fosamax 10 mg tablets following a single, oral 40 mg (4 x 10 mg) dose administra...
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 :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2002
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00983996
Start Date
June 1 2002
End Date
July 1 2002
Last Update
September 24 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
PRACS Insitute Ltd.
Fargo, North Dakota, United States, 58104