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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Alendronate Sodium Tablets, 10 mg; Drug: Fosamax Tablets, 10 mg

• Registration Number: NCT00983996
• Lead Sponsor: Mylan Pharmaceuticals Inc

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Primary Completion: 2002-07
• Study Completion: 2002-07
• Status Verified: 2009-09
• Study First Submitted: 2009-09-21
• Study First Submitted QC: 2009-09-22
• Last Update Submitted: 2009-09-22
• Study First Posted: 2009-09-24
• Last Update Posted: 2009-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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, 10 mg	Alendronate Sodium Tablets, 10 mg
2	Fosamax Tablets, 10 mg	Fosamax Tablets, 10 mg

Primary Outcome Measures

Name	Time	Method
Bioequivalence	urine collection up to 36 hours

Trial Locations

Locations (1)

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