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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00978055
First Posted: September 16, 2009
Last Update Posted: September 16, 2009
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.
Information provided by:
Mylan Pharmaceuticals
  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: None (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:


Further study details as provided by Mylan Pharmaceuticals:

Primary Outcome Measures:
  • Bioequivalence [ Time Frame: within 30 days ]

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

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 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
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): NCT00978055


Locations
United States, North Dakota
PRACS Institute, 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: NCT00978055     History of Changes
Other Study ID Numbers: LIOT-0592
First Submitted: September 15, 2009
First Posted: September 16, 2009
Last Update Posted: September 16, 2009
Last Verified: September 2009