clinical trial · NCT00648700
Fasting Study of Levothyroxine Sodium Tablets 300 μg to Levothroid® Tablets 300 μg
HealthyLevothyroxine Sodium Tablets 300 μgLevothroid® Tablets 300 μg
brief 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.
started
Aug 1, 2005
primary completion
Sep 1, 2005
completion
Sep 1, 2005
last updated
Apr 24, 2024
official title
Single-Dose Fasting In Vivo Bioequivalence Study of Levothyroxine Sodium Tablets (300 μg; Mylan) to Levothroid® Tablets (300 μg; Llyod) in Healthy Volunteers.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol