Fasting Study of Alendronate Sodium Tablets (10 mg) and Fosamax Tablets (10 mg)

Completed · Phase 1

Conditions studied: Healthy

In brief

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 administration under fasting conditions.

Key facts

Study ID

NCT00983996

Run by

Mylan Pharmaceuticals Inc

People needed

112

Starts

2002-06-01

Expected to finish

2002-07-01

Last updated by the study team

2009-09-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• healthy, adult subjects, 18 years and older
• able to swallow medication

You may not qualify if…

• 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

Where it is running

• PRACS Insitute Ltd. — Fargo, North Dakota, United States

Full record on ClinicalTrials.gov

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