At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 44 enrolled
Drug / intervention
Reference Eutirox® +1 moredrug
Likely dose
Reference Eutirox® 600 microgramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany·interventional·Posted Jun 7, 2019·Updated Feb 5, 2021
In Brief
A Phase 1 clinical trial evaluating Reference Eutirox® and Test Eutirox® for Healthy. Completed, enrolled 44 participants across 1 site.
Detailed Summary
The study investigated the bioequivalence between the new and the approved formulation for levothyroxine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesMexico
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
First PostedJun 2019
Enrollment StartDec 2019
Primary CompletionJan 2020
Study CompletionJan 2020
TodayJul 2026
First PostedJun 7, 2019
Enrollment StartDec 6, 2019
Primary CompletionJan 13, 2020
Study CompletionJan 25, 2020
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 7.1 years ago
Interventions
Reference Eutirox®drug
Participants received single oral dose of Reference Eutirox® 600 microgram (3 tablets of 200 microgram) either in treatment period 1 or 2.
Test Eutirox®drug
Participants received single oral dose of Test Eutirox® 600 microgram (3 tablets of 200 microgram) either in treatment 1 or 2.