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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01012934
Recruitment Status : Completed
First Posted : November 13, 2009
Last Update Posted : November 13, 2009
Sponsor:
Information provided by:

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  (Clinical Trial)
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 : July 2002
Primary Completion Date : August 2002
Study Completion Date : August 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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. [ Time Frame: urine collection up to 36 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01012934


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

Additional Information:
Responsible Party: Wayne Talton, Mylan Inc.
ClinicalTrials.gov Identifier: NCT01012934     History of Changes
Other Study ID Numbers: ALEN-0244
First Posted: November 13, 2009    Key Record Dates
Last Update Posted: November 13, 2009
Last Verified: November 2009

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