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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
  Purpose

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.


Condition Intervention Phase
Healthy
 Drug: 1: Liothyronine Sodium Tablets
Drug: 2: Cytomel® Tablets
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Single-Dose Fasting Bioequivalence Study of Liothyronine Sodium Tablets (50 Mcg; Mylan) to Cytomel® Tablets (50 Mcg; King) in Healthy Euthyroid Adult Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mylan Pharmaceuticals:

Primary Outcome Measures:
  • Bioequivalence [ Time Frame: within 30 days ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: October 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Liothyronine Sodium Tablets, 50 mcg
 Drug: 1: Liothyronine Sodium Tablets

Liothyronine Sodium Tablets, 50 mcg

2 x 50 mcg, single-dose, fasting
Active Comparator: 2
Cytomel® Tablets, 50 mcg
 Drug: 2: Cytomel® Tablets

Cytomel® Tablets, 50 mcg

2 x 50 mcg, 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00978055

Locations
United States, North Dakota
PRACS Institute, 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: NCT00978055     History of Changes
Other Study ID Numbers: LIOT-0592
Study First Received: September 15, 2009
Last Updated: September 15, 2009
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013