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

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2005
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.
Epistemonikos ID: d99fac3fd47b014a53c698da7547abddc596cb49
First added on: May 04, 2024