drugset
drugset / Trial / NCT03979274

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

NCT03979274 ↗

Phase 1 Completed 44 enrolled Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
RandomizedCrossoverOpen-labelOther

Summary

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

Timeline

Start
2019-12-06
Primary completion
2020-01-13
Completion
2020-01-25

Outcome

Met primary endpoint

registry analysis (equivalence test); Refernece Eutirox® vs Test Eutirox®; Geometric mean ratio 98.53 (90% CI 94.55 to 102.68) NCT03979274 ↗

registry analysis (equivalence test); Refernece Eutirox® vs Test Eutirox®; Geometric mean ratio 97.59 (90% CI 91.34 to 104.26) NCT03979274 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Levothyroxine Other / unclassified 600 ug Oral

Indications

No indication recorded.