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

This study has been completed.
Sponsor:
Information provided by:
Mylan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01012934
First received: September 21, 2009
Last updated: November 12, 2009
Last verified: November 2009
History of Changes
  Purpose

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 Intervention Phase
Healthy
 Drug: Alendronate Sodium Tablets, 70 mg
Drug: Fosamax Tablets, 70 mg
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mylan Pharmaceuticals:

Primary Outcome Measures:
  • 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. [ Time Frame: urine collection up to 36 hours ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: July 2002
Study Completion Date: August 2002
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01012934

Locations
United States, North Dakota
PRACS Insitute Ltd.
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Mylan Pharmaceuticals
  More Information

Additional Information:
Mylan Pharmaceuticals Inc. - Clinical Trial Results  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Wayne Talton, Mylan Inc.
ClinicalTrials.gov Identifier: NCT01012934     History of Changes
Other Study ID Numbers: ALEN-0244
Study First Received: September 21, 2009
Last Updated: November 12, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013