NCT03979274

A Comparative Study of New Formulation and Approved Formulation for Levothyroxine in Healthy Volunteers

Prospective, Single Dose, Randomized, Open Label, Comparative, Cross-study to Establish Bioequivalence Between the New Formulation and the Approved Formulation for Levothyroxine (Eutirox® From Merck, S. A. de C. V.) Given as 3 Tablets of 200 μg p.o. in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The study investigated the bioequivalence between the new and the approved formulation for levothyroxine.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Reference Eutirox®	Participants received single oral dose of Reference Eutirox® 600 microgram (3 tablets of 200 microgram) either in treatment period 1 or 2.
DRUG	Test Eutirox®	Participants received single oral dose of Test Eutirox® 600 microgram (3 tablets of 200 microgram) either in treatment 1 or 2.

Timeline

• Start date: 2019-12-06
• Primary completion: 2020-01-13
• Completion: 2020-01-25
• First posted: 2019-06-07
• Last updated: 2021-02-05
• Results posted: 2021-02-05

Locations

1 site across 1 country: Mexico