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

Mylan Pharmaceuticals Inc · 2005
ClinicalTrials.gov · Datasets · License: Public Domain · 2005
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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.
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