NCT01133496

Bioequivalence Study of Alendronate Sodium Tablets 70 mg of Dr. Reddy's Under Fasting Conditions

Open Label, Balanced, Randomized, Two-way, Single-dose, Crossover Bioequivalence Study of Alendronate Sodium 70 mg Tablets of Dr Reddy's, India and Fosamax® Tablets of Merck & Co., Inc., USA, in Healthy Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the bioequivalence of Alendronate Sodium 70 mg of Dr. Reddy's and Fosamax Tablets 70 mg of Merck \& Co.

Detailed description

Open label, balanced, randomized, two-treatment, two-sequence, two-period, single-dose, crossover oral bioequivalence study of Alendronate sodium 70 mg tablets of Dr Reddy's Laboratories Limited, India and Fosamax® tablets of Merck \& Co., Inc., USA, in healthy, adult, human subjects under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Alendronate Sodium Tablets, 70 mg	Alendronate Sodium Tablets, 70 mg of Dr. Reddy's Laboratories Limited.

Timeline

• Start date: 2006-12-01
• Primary completion: 2006-12-01
• Completion: 2007-04-01
• First posted: 2010-05-28
• Last updated: 2010-06-14

Locations

1 site across 1 country: India