Fasting Study of Levothyroxine Sodium Tablets 300 μg to Levothroid® Tablets 300 μg
Status:
Completed
Trial end date:
2005-09-01
Target enrollment:
Participant gender:
Summary
The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine
sodium 300 μg tablets to 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.