NCT00647855

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (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 Abbott's Synthroid® 300 μg tablets following a single 600 μg (2 x 300 μg) dose administered in healthy volunteers under fasting conditions. Single-dose pharmacokinetic parameters for baseline corrected total L-thyroxine and non-baseline corrected total L-triiodothyronine were calculated using noncompartmental techniques.

Conditions

• Healthy

Interventions

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

Timeline

• Start date: 2003-05-01
• Primary completion: 2003-06-01
• Completion: 2003-06-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States