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

• Sponsor: Mylan Pharmaceuticals Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01012934
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Arms: 2
• Duration (Months): 1
• Patients Per Site Per Month: 108

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Alendronate Sodium Tablets, 70 mg; Drug: Fosamax Tablets, 70 mg	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: Single-Dose Fasting In Vivo Bioequivalence Study of Alendronate Sodium Tablets (70 mg; Mylan) and Fosamax Tablets (70 mg; Merck) in Healthy Volunteers
• Study Start Date: Jul 1, 2002
• Actual Primary Completion Date: Aug 1, 2002
• Actual Study Completion Date: Aug 1, 2002

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Alendronate Sodium Tablets, 70 mg	Drug: Alendronate Sodium Tablets, 70 mg; 1 x 70 mg, single-dose fasting
Active Comparator: 2 Fosamax Tablets, 70 mg	Drug: Fosamax Tablets, 70 mg; 1 x 70 mg, single-dose fasting

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRACS Insitute Ltd.	Fargo	North Dakota	United States	58104

Sponsors and Collaborators

• Mylan Pharmaceuticals Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mylan Pharmaceuticals Inc. - Clinical Trial Results

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01012934
• Other Study ID Numbers: ALEN-0244
• First Posted: Nov 13, 2009
• Last Update Posted: Nov 13, 2009
• Last Verified: Nov 1, 2009

• Additional relevant MeSH terms: Alendronate

Study Results

No Results Posted as of Nov 13, 2009