NCT00648557

Fasting Study of Levothyroxine Sodium Tablets 200 mg to Synthroid Tablets 200 mg

Single-Dose Fasting In Vivo Bioequivalence Study of Levothyroxine Sodium Tablets (200 mg; Mylan) to Synthroid Tablets (200 mg; Abbott) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Levothyroxine Sodium Tablets 200 mg	3x200mcg, single dose fasting
DRUG	Synthroid Tablets 200 mg	3x200mcg, single dose fasting

Timeline

• Start date: 2003-01-01
• Primary completion: 2003-03-01
• Completion: 2003-03-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States