NCT00648882

Fasting Study of Levothyroxine Sodium Tablets 300 mcg to Synthroid® Tablets 300 mcg

Single-Dose Fasting Bioequivalence Study of Levothyroxine Sodium Tablets (300 mcg; Mylan) to Synthroid® Tablets (300 mcg; Abbott)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine sodium 300 mcg tablets to Abbott's Synthroid® 300 mcg tablets following a single, oral 600 mcg dose (2 × 300 mcg) administered under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	LEVOTHYROXINE SODIUM TABLETS,	2x300mcg, single dose fasting
DRUG	SYNTHROID® 300 mcg Tablets	2x300mcg, single dose fasting

Timeline

• Start date: 2007-03-01
• Primary completion: 2007-04-01
• Completion: 2007-05-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States