Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Eutirox · 1 trial · 1 indication
Cmax was obtained from the concentration time curve. Cmax\[aj\] was the maximum serum concentration in pre dose corrected data where pre dose corrected data was obtained by subtracting pre dose level of Levothyroxine (T4) from level of Levothyroxine (T4) after administration.
AUC0-t was defined as area under the curve of the serum concentration as a function of time, from time 0 until the last sampling time by means of the trapezoidal rule. AUC0-t \[aj\] was the area under the serum concentration-time curve from time zero to the last sampling time in pre dose corrected data where pre dose corrected data was obtained by subtracting pre dose level of Levothyroxine (T4) from level of Levothyroxine (T4) after administration.
| Arm | Type | Description |
|---|---|---|
| Reference Eutirox®, then Test Eutirox® | EXPERIMENTAL | Participants received single oral dose of Reference Eutirox® 600 microgram (mcg) (3 tablets of 200 mcg) in Treatment Period 1 followed by single oral dosing of Test Eutirox® 600 mcg (3 tablets of 200 mcg) in Treatment Period 2. A wash-out period of 35 days was maintained between the Treatment Periods 1 and 2. |
| Test Eutirox®, then Reference Eutirox® | EXPERIMENTAL | Participants received single oral dose of Test Eutirox® 600 mcg (3 tablets of 200 mcg) in Treatment Period 1 followed by single oral dosing of Reference Eutirox® 600 mcg (3 tablets of 200 mcg) in Treatment Period 2. A wash-out period of 35 days was maintained between the Treatment Periods 1 and 2. |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: * Participants who have provided their written consent prior to any study-related activity * Ethnic origin: Mexicans * Body mass index from 18 to 27 kilogram per meter square (kg/m\^2) * Normal vital signs (includes heart rate between 50 and 100 beats per minute, respiratory rat...
Eutirox is a small molecule medicine developed by Merck KGaA. It has been studied in a Phase 1 clinical trial in healthy adult volunteers, comparing a new formulation against an approved formulation. The trial, NCT03979274, was completed with 44 participants in Mexico.
Eutirox has been studied in healthy volunteers rather than in a patient population. The completed Phase 1 trial evaluated a new formulation against an approved formulation in 44 healthy adults. No patient indication has been studied in the available clinical program.
Eutirox is developed by Merck KGaA, which trades under the ticker MKGAF. The company sponsored the Phase 1 comparative study of a new formulation and an approved formulation in healthy volunteers.
Eutirox is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are ongoing. The study enrolled 44 healthy volunteers and was randomized and controlled, though not double blind.
Eutirox has been evaluated in one completed Phase 1 trial, NCT03979274, titled A Comparative Study of New Formulation and Approved Formulation for Levothyroxine in Healthy Volunteers. It enrolled 44 participants in Mexico, was randomized and controlled, and included adults aged 18 years and older of all sexes.
Yes, Eutirox and Eutirox® refer to the same medicine. Eutirox® is the registered trademark form of the name used by Merck KGaA. Searches for either term point to the same Phase 1 development program.