NCT00648700

Fasting Study of Levothyroxine Sodium Tablets 300 μg to Levothroid® Tablets 300 μg

Single-Dose Fasting In Vivo Bioequivalence Study of Levothyroxine Sodium Tablets (300 μg; Mylan) to Levothroid® Tablets (300 μg; Llyod) in Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (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 μg tablets to Lloyd's Levothroid® 300 μg tablets following a single 600 μg (2 x 300 μg) dose administered in healthy adult volunteers under fasting conditions. Statistical analysis of the data revealed that 90% confidence intervals were within the acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters LNAUC0-48hr and LNCPEAK for baseline corrected total levothyroxine.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Levothyroxine Sodium Tablets 300 μg	2x300mcg, single dose fasting
DRUG	Levothroid® Tablets 300 μg	2x300mcg, single dose fasting

Timeline

• Start date: 2005-08-01
• Primary completion: 2005-09-01
• Completion: 2005-09-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States