NCT00983996

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

Single-Dose Fasting In Vivo Bioequivalence Study of Alendronate Sodium Tablets (10 mg; Mylan) and Fosamax Tablets (10 mg; Merck) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Alendronate Sodium Tablets, 10 mg	10 mg, single-dose fasting
DRUG	Fosamax Tablets, 10 mg	10 mg, single-dose fasting

Timeline

• Start date: 2002-06-01
• Primary completion: 2002-07-01
• Completion: 2002-07-01
• First posted: 2009-09-24
• Last updated: 2009-09-24

Locations

1 site across 1 country: United States