Fasting Study of Levothyroxine Sodium Tablets 300 μg to Synthroid® Tablets 300 μg
Status:
Completed
Trial end date:
2003-06-01
Target enrollment:
Participant gender:
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.