Fasting Study of Liothyronine Sodium Tablets (50 Mcg) to Cytomel® Tablets (50 Mcg)

This study has been completed.

Sponsor:

Information provided by:

Mylan Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00978055

First received: September 15, 2009

Last updated: NA

Last verified: September 2009

History: No changes posted

Tracking Information
First Received Date ^ICMJE	September 15, 2009
Last Updated Date	September 15, 2009
Start Date ^ICMJE	October 2007
Primary Completion Date	December 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 15, 2009)	Bioequivalence [ Time Frame: within 30 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
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 Liothyronine Sodium Tablets (50 Mcg) to Cytomel® Tablets (50 Mcg)
Official Title ^ICMJE	Single-Dose Fasting Bioequivalence Study of Liothyronine Sodium Tablets (50 Mcg; Mylan) to Cytomel® Tablets (50 Mcg; King) in Healthy Euthyroid Adult Volunteers
Brief Summary	The objective of this study was to investigate the bioequivalence of Mylan's liothyronine sodium 50 mcg tablets to King's Cytomel® 50 mcg tablets following a single, oral 100 mcg (2 x 50 mcg) 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: 1: Liothyronine Sodium Tablets Liothyronine Sodium Tablets, 50 mcg 2 x 50 mcg, single-dose, fasting Drug: 2: Cytomel® Tablets Cytomel® Tablets, 50 mcg 2 x 50 mcg, single-dose, fasting
Study Arm (s)	Experimental: 1 Liothyronine Sodium Tablets, 50 mcg Intervention: Drug: 1: Liothyronine Sodium Tablets Active Comparator: 2 Cytomel® Tablets, 50 mcg Intervention: Drug: 2: Cytomel® Tablets
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	31
Completion Date	December 2007
Primary Completion Date	December 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: healthy males and/or non-pregnant, non-lactating females, 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 prior to 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	NCT00978055
Other Study ID Numbers ^ICMJE	LIOT-0592
Has Data Monitoring Committee	Not Provided
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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