NCT00835406

Alendronate Sodium 70 mg Tablet Versus Fosamax® Under Fasting Conditions.

Randomized, 2-Way Crossover, Bioequivalence Study of Teva Pharmaceuticals USA and Merck Sharp & Dohme (USA) (Fosamax®) Alendronate Sodium Tablets Administered as a 1 x 70 mg in Healthy Adult Males Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare the rate and extent of absorption of alendronate sodium 70 mg tablets (test) versus Fosamax® 70 mg tablets (reference) administered as a single dose of 70 mg under fasting conditions. A review of pharmacokinetic data demonstrates Alendronate Sodium Tablets, 70 mg, manufactured and distributed by TEVA Pharmaceuticals USA are bioequivalent to Fosamax® Tablets, 70 mg, manufactured by Merck Sharp \& Dohme, USA.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

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

Timeline

• Start date: 2000-06-01
• Primary completion: 2000-07-01
• Completion: 2000-07-01
• First posted: 2009-02-03
• Last updated: 2009-07-09
• Results posted: 2009-06-11

Locations

1 site across 1 country: Canada