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 being studied in healthy volunteers. It is a formulation of levothyroxine sodium 200 micrograms (mcg) under tablet form. The drug is being developed by Merck KGaA and is currently in Phase 1 clinical development.
Puran T4 is being developed by Merck KGaA, a company traded under the ticker MKGAF. The drug is currently in Phase 1 clinical development as an investigational small molecule formulation of levothyroxine sodium.
Puran T4 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed, and the drug is not currently in active clinical trials.
Puran T4 has been studied in one completed Phase 1 clinical trial, NCT04037748. This trial assessed the bioequivalence of two formulations of levothyroxine sodium 200 mcg under tablet form in 72 healthy volunteers in Brazil. The trial was controlled but not double-blind.
Puran T4 is a formulation of levothyroxine sodium 200 mcg in tablet form. It is being studied for bioequivalence against another formulation of levothyroxine sodium. The drug is an investigational small molecule developed by Merck KGaA.