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

• Status: Completed
• Trial end date: 2002-07-01
• Target enrollment: 0
• Participant gender: All

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 administration under fasting conditions.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mylan Pharmaceuticals
• Treatments: Alendronate

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