NCT01012934

Fasting Study of Alendronate Sodium Tablets (70 mg) and Fosamax Tablets (70 mg)

Single-Dose Fasting In Vivo Bioequivalence Study of Alendronate Sodium Tablets (70 mg; Mylan) and Fosamax Tablets (70 mg; Merck) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 110 (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 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Alendronate Sodium Tablets, 70 mg	1 x 70 mg, single-dose fasting
DRUG	Fosamax Tablets, 70 mg	1 x 70 mg, single-dose fasting

Timeline

• Start date: 2002-07-01
• Primary completion: 2002-08-01
• Completion: 2002-08-01
• First posted: 2009-11-13
• Last updated: 2009-11-13

Locations

1 site across 1 country: United States