CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 72 enrolled
Drug / intervention
Puran T4® +1 moredrug
Likely dose
Puran T4® 600 mcgfrom 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.

Search/NCT04037748
NCT04037748Phase 1Completed
CompareCT.gov

A Prospective, Single Dose, Randomized, Open-label, Crossover, Comparative Study to Establish Bioequivalence in Healthy Subjects Between the Puran T4® (Sanofi Aventis Farmacêutica Ltda) vs. the New Formulation of Levothyroxine (Eutirox NF® Merck) Administered Orally as 3 Tablets of 200 μg

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany·interventional·Posted Jul 30, 2019·Updated Sep 29, 2020

In Brief

A Phase 1 clinical trial evaluating Puran T4® and Eutirox® for Healthy. Completed, enrolled 72 participants across 1 site.

Detailed Summary

The study was to verify if the test formulation of Levothyroxine sodium presents an equivalent rate and extension of absorption to the comparator formulation when administered with the same dosage and under fasting conditions and after baseline correction concentrations.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesBrazil
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedJul 30, 2019
Enrollment StartJun 25, 2019
Primary CompletionSep 11, 2019
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.9 years ago

Interventions

Puran T4®drug

Participants who received a single oral dose of Puran T4® 600 mcg tablets (3 tablets of 200 mcg Levothyroxine sodium) in either Treatment Period 1 or 2 under fasting conditions.

Eutirox®drug

Participants who received a single oral dose of Eutirox® 600 mcg tablets (3 tablets of 200 mcg Levothyroxine sodium) in either Treatment Period 1 or 2 under fasting conditions.