Fasting Study of Levothyroxine Sodium Tablets 200 mg to Synthroid Tablets 200 mg
Status:
Completed
Trial end date:
2003-03-01
Target enrollment:
Participant gender:
Summary
The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine
sodium 200 μg tablets to Abbott's Synthroid® 200 μg tablets following a single 600 μg (3 x
200 μg) dose administration in healthy volunteers under fasting conditions. Twenty-nine
healthy, non-smoking, subjects between the ages of 18 and 47 completed this open-label,
randomized, two-period, two-treatment, single-dose crossover study conducted by Dr. James D.
Carlson at PRACS Institute, Ltd., Fargo, ND. 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
L-thyroxine. This study demonstrated that Mylan's 200 μg levothyroxine sodium tablets are
bioequivalent to Abbott's Synthroid® 200 μg tablets following a single, oral 600 μg (3 x 200
μg) dose under fasting conditions