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

Information source: Mylan Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: 1: Liothyronine Sodium Tablets (Drug); 2: Cytomel® Tablets (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Mylan Pharmaceuticals


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.

Clinical Details

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 design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Bioequivalence


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

PRACS Institute, Ltd., Fargo, North Dakota 58104, United States
Additional Information

Mylan Pharmaceuticals Inc. - Clinical Trial Results

Starting date: October 2007
Last updated: September 15, 2009

Page last updated: August 23, 2015

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