Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Cesol (Test)
Cesol · 1 trial · 1 indication
Cmax was obtained directly from the concentration versus time curve.
Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule.
| Arm | Type | Description |
|---|---|---|
| Sequence 1 (T1-R1-T2-R2) | EXPERIMENTAL | Participants will receive first dose of Cesol on Day 1 in treatment period 1 followed by first dose of Biltricide on Day 8 in treatment period 2 followed by second dose of Cesol on Day 15 in treatment period 3 followed by second dose of Biltricide on Day 22 in treatment period 4. A washout period of 7 days will be maintained between 4 treatment periods. |
| Sequence 2 (R1-T1-R2-T2) | EXPERIMENTAL | Participants will receive first dose of Biltricide on Day 1 in treatment period 1 followed by first dose of Cesol on Day 8 in treatment period 2 followed by second dose of Biltricide on Day 15 in treatment period 3 followed by second dose of Cesol on Day 22 in treatment period 4. A washout period of 7 days will be maintained between 4 treatment periods. |
| Name | Type | Description |
|---|---|---|
| Cesol (Test) | DRUG | Participant will receive coated cesol tablet in sequence 1 (Day 1 and Day 15) and in sequence 2 (Day 8 and Day 22). A washout period of 7 days will be maintained between 4 treatment periods. |
| Biltricide (Reference) | DRUG | Participant will receive biltricide tablet in Sequence 1 (Day 8 and Day 22) and in sequence 2 (Day 1 and Day 15). A washout period of 7 days will be maintained between 4 treatment periods. |
Inclusion Criteria: * Participants who are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring * Nonsmoker (=0 cigarettes, pipes, cigars or others) since at least 3 months * Have a body weight within 55.0 to ...
Cesol is a small molecule drug developed by Merck KGaA. It is in Phase 1 clinical development, and its specific therapeutic indication has not been publicly disclosed. One completed Phase 1 trial has evaluated the drug, and no active trials are currently listed.
Cesol is developed by Merck KGaA, which trades under the ticker MKGAF. The company is responsible for the clinical development of the drug, including the completed Phase 1 bioequivalence study conducted in Germany.
Cesol is in Phase 1 clinical development. One Phase 1 trial has been completed, and there are no active trials currently listed. The drug has not been approved by the FDA, and it remains an investigational product.
Cesol has been evaluated in one completed Phase 1 trial, NCT04314037, titled Bioequivalence Study of Coated Cesol Tablet Formulation Versus Biltricide. The trial enrolled 36 healthy male volunteers in Germany and was a randomized, controlled study.
Cesol and Biltricide are not the same product. A completed Phase 1 trial compared a coated Cesol tablet formulation against Biltricide to assess bioequivalence. Cesol is also referred to as Cesol or Cesol (Test) in study documentation.