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

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.

Timeline

Start

2003-05

Primary completion

2003-06

Completion

2003-06

Drugs

Indications

No indication recorded.