NCT06547242

Levothyroxine-sodium Bioequivalence Trial With Oral Single Dose Administration

Bioequivalence Trial of BC-T4CYS 150 µg Tablets Versus Letrox® 150 µg in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Berlin-Chemie AG Menarini Group · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Levothyroxine-sodium Bioequivalence Trial With Oral Single Dose Administration

Detailed description

Single centre, open-label, randomised (order of treatments), balanced, 2-period, 2-sequence, single dose cross-over trial with administrations under fasting conditions separated by a washout period of at least 45 treatment-free days

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Levothyroxin	Single-dose administration of 600 mcg of Levothyroxin for the assessment of bioequivalence
DRUG	Levothyroxin	Single-dose administration of 600 mcg of Levothyroxin for the assessment of bioequivalence

Timeline

• Start date: 2021-10-22
• Primary completion: 2022-03-22
• Completion: 2022-05-22
• First posted: 2024-08-09
• Last updated: 2024-08-09

Locations

1 site across 1 country: Germany