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

• Sponsor: Mylan Pharmaceuticals Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00983996
• Collaborator: (none)
• Enrollment: 112
• Location: 1
• Arms: 2
• Duration (Days): 30
• Patients Per Site Per Month: 113.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Alendronate Sodium Tablets, 10 mg; Drug: Fosamax Tablets, 10 mg	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 112 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: Single-Dose Fasting In Vivo Bioequivalence Study of Alendronate Sodium Tablets (10 mg; Mylan) and Fosamax Tablets (10 mg; Merck) in Healthy Volunteers
• Study Start Date: Jun 1, 2002
• Actual Primary Completion Date: Jul 1, 2002
• Actual Study Completion Date: Jul 1, 2002

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Alendronate Sodium Tablets, 10 mg	Drug: Alendronate Sodium Tablets, 10 mg; 10 mg, single-dose fasting
Active Comparator: 2 Fosamax Tablets, 10 mg	Drug: Fosamax Tablets, 10 mg; 10 mg, single-dose fasting

Outcome Measures

Primary Outcome Measures

1. Bioequivalence [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: NCT00983996
• Other Study ID Numbers: ALEN-0243
• First Posted: Sep 24, 2009
• Last Update Posted: Sep 24, 2009
• Last Verified: Sep 1, 2009

• Additional relevant MeSH terms: Alendronate

Study Results

No Results Posted as of Sep 24, 2009