drugset / Trial / NCT00648700
Fasting Study of Levothyroxine Sodium Tablets 300 μg to Levothroid® Tablets 300 μg
RandomizedCrossoverOpen-labelOther
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.
Timeline
- Start
- 2005-08
- Primary completion
- 2005-09
- Completion
- 2005-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Levothyroxine | Other / unclassified | 600 ug | — |
Indications
No indication recorded.