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

This study has been completed.

Sponsor:

Information provided by:

Mylan Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00983996

First received: September 21, 2009

Last updated: September 22, 2009

Last verified: September 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	September 21, 2009
Last Updated Date	September 22, 2009
Start Date ^ICMJE	June 2002
Primary Completion Date	July 2002 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 22, 2009)	Bioequivalence [ Time Frame: urine collection up to 36 hours ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00983996 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Fasting Study of Alendronate Sodium Tablets (10 mg) and Fosamax Tablets (10 mg)
Official Title ^ICMJE	Single-Dose Fasting In Vivo Bioequivalence Study of Alendronate Sodium Tablets (10 mg; Mylan) and Fosamax Tablets (10 mg; Merck) in Healthy Volunteers
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label
Condition ^ICMJE	Healthy
Intervention ^ICMJE	Drug: Alendronate Sodium Tablets, 10 mg 10 mg, single-dose fasting Drug: Fosamax Tablets, 10 mg 10 mg, single-dose fasting
Study Arm (s)	Experimental: 1 Alendronate Sodium Tablets, 10 mg Intervention: Drug: Alendronate Sodium Tablets, 10 mg Active Comparator: 2 Fosamax Tablets, 10 mg Intervention: Drug: Fosamax Tablets, 10 mg
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	112
Completion Date	July 2002
Primary Completion Date	July 2002 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00983996
Other Study ID Numbers ^ICMJE	ALEN-0243
Has Data Monitoring Committee	No
Responsible Party	Wayne Talton, Mylan Inc.
Study Sponsor ^ICMJE	Mylan Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Mylan Pharmaceuticals
Verification Date	September 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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