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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Alendronate Sodium Tablets, 70 mg; Drug: Fosamax Tablets, 70 mg

• Registration Number: NCT01012934
• Lead Sponsor: Mylan Pharmaceuticals Inc

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-07
• Primary Completion: 2002-08
• Study Completion: 2002-08
• Study First Submitted: 2009-09-21
• Status Verified: 2009-11
• Study First Submitted QC: 2009-11-12
• Last Update Submitted: 2009-11-12
• Study First Posted: 2009-11-13
• Last Update Posted: 2009-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Alendronate Sodium Tablets, 70 mg	Alendronate Sodium Tablets, 70 mg
2	Fosamax Tablets, 70 mg	Fosamax Tablets, 70 mg

Primary Outcome Measures

Name	Time	Method
The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.	urine collection up to 36 hours

Trial Locations

Locations (1)

PRACS Insitute Ltd.; 🇺🇸 Fargo, North Dakota, United States