Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Puran T4 · 1 trial · 1 indication
Cmax was obtained from plasma concentration time curve. Maximum plasmatic concentration observed adjusted by basal level correction was reported.
The AUC 0-72 was defined as the area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours post-dose. Area under the plasma curve from time 0 hours to time 72 hours adjusted by basal levels correction was reported.
| Arm | Type | Description |
|---|---|---|
| First Puran T4®, then Eutirox® | EXPERIMENTAL | Participants received single oral dose of Puran T4® 600 micrograms (mcg) (3 tablets of 200 mcg Levothyroxine sodium) in Treatment Period 1 followed by single oral dose of Eutirox® 600 mcg (3 tablets of 200 mcg Levothyroxine sodium) in Treatment Period 2 under fasting conditions. A wash-out period of 70 days was maintained between the Treatment Periods 1 and 2. |
| First Eutirox®, then Puran T4® | EXPERIMENTAL | Participants received single oral dose of Eutirox® 600 mcg (3 tablets of 200 mcg Levothyroxine sodium) in Treatment Period 1 followed by single oral dose of Puran T4® 600 mcg (3 tablets of 200 mcg Levothyroxine sodium) in Treatment Period 2 under fasting conditions. A wash-out period of 70 days was maintained between the Treatment Periods 1 and 2. |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: * To have freely agreed and signed the consent form, after all essential elements of the protocol have been clarified, before any procedure * Body Mass Index (BMI) of the research participants must be comprised within the range of 18.50 to 27.00 * No abnormal findings on medical...
Puran T4 is an investigational small molecule developed by Merck KGaA. It has been studied in a Phase 1 bioequivalence trial comparing two tablet formulations of levothyroxine sodium 200 micrograms in healthy adult volunteers. The specific therapeutic indication for Puran T4 has not been disclosed.
Puran T4 is made by Merck KGaA, which trades under the ticker MKGAF. The company is the developer of the drug and sponsored the clinical trial evaluating its bioequivalence.
Puran T4 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA.
Puran T4 has been evaluated in one completed Phase 1 trial, NCT04037748, titled Bioequivalence of Two Formulations of Levothyroxine Sodium 200 Micrograms (mcg) Under Tablet Form. The trial enrolled 72 healthy adult volunteers in Brazil and used a randomized, controlled design.
Yes, Puran T4 and Puran T4® refer to the same product. Puran T4® is the registered trademark name for the drug developed by Merck KGaA.