Fasting Study of Alendronate Sodium Tablets (70 mg) and Fosamax Tablets (70 mg)
Information source: Mylan Pharmaceuticals
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Alendronate Sodium Tablets, 70 mg (Drug); Fosamax Tablets, 70 mg (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Mylan Pharmaceuticals
Summary
The objective of this study is to investigate the bioequivalence of Mylan's alendronate
sodium 70 mg tablets to Merck's Fosamax 70 mg tablets following a single, oral 70 mg (1 x 70
mg) dose administration under fasting conditions.
Clinical Details
Official title: Single-Dose Fasting In Vivo Bioequivalence Study of Alendronate Sodium Tablets (70 mg; Mylan) and Fosamax Tablets (70 mg; Merck) in Healthy Volunteers
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- healthy, adult subjects, 18 years and older
- able to swallow medication
Exclusion Criteria:
- 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
Locations and Contacts
PRACS Insitute Ltd., Fargo, North Dakota 58104, United States
Additional Information
Mylan Pharmaceuticals Inc. - Clinical Trial Results
Starting date: July 2002
Last updated: November 12, 2009
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