Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Eutirox®
Reference 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 therapeutic developed by Merck KGaA. It is in Phase 1 clinical development. The specific indications for Eutirox are undisclosed, and it is classified within a therapeutic area outside the main categories. Eutirox is also known as Reference Eutirox and Eutirox.
Eutirox is developed by Merck KGaA, which trades under the ticker MKGAF. Merck KGaA is the company responsible for the clinical development of Eutirox, including the Phase 1 study conducted in Mexico.
Eutirox is in Phase 1 clinical development. It has completed one Phase 1 trial and has no active trials at this time. Eutirox is investigational and has not been approved by the FDA for any indication.
Eutirox has been studied in one completed Phase 1 trial, NCT03979274, titled A Comparative Study of New Formulation and Approved Formulation for Levothyroxine in Healthy Volunteers. The trial enrolled 44 healthy volunteers in Mexico, was randomized and controlled, and included both male and female participants aged 18 years and older.
Yes, Eutirox is also known as Reference Eutirox, Reference Eutirox, and Eutirox. These names refer to the same investigational small molecule therapeutic developed by Merck KGaA. Searches for any of these alternative names will lead to the same drug asset.