NCT05174000

BE of Euthyrox® Tablets (Merck Nantong Versus Merck Darmstadt Sites)

An Open-label, Single-dose, Randomized, 4-period, 2-sequence, Fully Replicated Crossover, Single-center Phase I Study to Assess Bioequivalence in Healthy Participants Between Euthyrox® Tablets Manufactured at Merck Nantong Versus Euthyrox® Tablets Manufactured at Merck Darmstadt Administered Orally as 12 Tablets of 50 μg

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to demonstrate bioequivalence (BE) between Euthyrox® tablets manufactured at Merck Nantong (Test Euthyrox) versus the tablets manufactured at Merck Darmstadt (Reference Euthyrox).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Test Euthyrox®	Participants will receive single oral dose of Test Euthyrox® either in treatment period 1, 2, 3 or 4.
DRUG	Reference Euthyrox®	Participants will receive single oral dose of Reference Euthyrox® either in treatment period 1, 2, 3 or 4.

Timeline

• Start date: 2022-01-10
• Primary completion: 2022-10-18
• Completion: 2022-10-18
• First posted: 2021-12-30
• Last updated: 2022-11-25

Locations

1 site across 1 country: China