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

NCT00978055 — Phase 1, Completed, 31 participants, Mylan Pharmaceuticals Inc

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Single-Dose Fasting Bioequivalence Study of Liothyronine Sodium Tablets (50 Mcg; Mylan) to Cytomel® Tablets (50 Mcg; King) in Healthy Euthyroid Adult Volunteers

Registry	NCT00978055
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none
Enrollment	31 (Actual)
Sponsor	Mylan Pharmaceuticals Inc (Industry)
Conditions	Healthy
Interventions	1: Liothyronine Sodium Tablets, 2: Cytomel® Tablets (Drug)
Dates	start 2007-10-01, primary completion 2007-12-01, completion 2007-12-01, first posted 2009-09-16, last updated 2009-09-16
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
1	Experimental	Drug: 1: Liothyronine Sodium Tablets	Liothyronine Sodium Tablets, 50 mcg
2	Active comparator	Drug: 2: Cytomel® Tablets	Cytomel® Tablets, 50 mcg

1: Liothyronine Sodium Tablets (Drug): Liothyronine Sodium Tablets, 50 mcg 2 x 50 mcg, single-dose, fasting
2: Cytomel® Tablets (Drug): Cytomel® Tablets, 50 mcg 2 x 50 mcg, single-dose, fasting

+Outcome measures

Primary outcomes

Bioequivalence [within 30 days]

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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 (1)

Facility	City	Country	Status
PRACS Institute, Ltd.	Fargo, North Dakota	United States