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

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ClinicalTrials.gov Identifier: NCT00978055
Recruitment Status : Completed
First Posted : September 16, 2009
Last Update Posted : September 16, 2009
Sponsor:
Information provided by:
Mylan Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: 1: Liothyronine Sodium Tablets Drug: 2: Cytomel® Tablets Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
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
Study Start Date : October 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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




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


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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

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

Additional Information:
Responsible Party: Wayne Talton, Mylan, Inc.
ClinicalTrials.gov Identifier: NCT00978055     History of Changes
Other Study ID Numbers: LIOT-0592
First Posted: September 16, 2009    Key Record Dates
Last Update Posted: September 16, 2009
Last Verified: September 2009