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

NCT05174000 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2022-11-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-10
Primary Completion
2022-10-18
Completion
2022-10-18

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05174000 on ClinicalTrials.gov