Fasting Study of Levothyroxine Sodium Tablets 300 μg to Levothroid® Tablets 300 μg
Completed
Mylan Pharmaceuticals
Phase 1
2005-08-01
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.
Treatment Trial of Subclinical Hypothyroidism in Down Syndrome
Completed
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
N/A
2013-01-01
The purpose of this research study is to learn about the effects of treating subclinical
hypothyroidism (SCH) with thyroid hormone replacement in children and adolescents with Down
syndrome (DS). We hypothesize that treatment of SCH with thyroid hormone replacement will
improve cardiometabolic health and quality of life.
Treatment Trial of Subclinical Hypothyroidism in Down Syndrome
Completed
Children's Hospital of Philadelphia
N/A
2013-01-01
The purpose of this research study is to learn about the effects of treating subclinical
hypothyroidism (SCH) with thyroid hormone replacement in children and adolescents with Down
syndrome (DS). We hypothesize that treatment of SCH with thyroid hormone replacement will
improve cardiometabolic health and quality of life.
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