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

September 15, 2009
September 15, 2009
October 2007
December 2007   (final data collection date for primary outcome measure)
Bioequivalence [ Time Frame: within 30 days ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Fasting Study of Liothyronine Sodium Tablets (50 Mcg) to Cytomel® Tablets (50 Mcg)
Single-Dose Fasting Bioequivalence Study of Liothyronine Sodium Tablets (50 Mcg; Mylan) to Cytomel® Tablets (50 Mcg; King) in Healthy Euthyroid Adult Volunteers

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • 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

  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00978055
LIOT-0592
Not Provided
Wayne Talton, Mylan, Inc.
Mylan Pharmaceuticals
Not Provided
Not Provided
Mylan Pharmaceuticals
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP