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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


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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 20, 2015

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