NCT00978055

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 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 across 1 country: United States