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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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 September 27, 2016