Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being developed by Merck KGaA. It is currently in Phase 1 clinical development, with one completed trial involving healthy volunteers. The drug is being studied for use in healthy individuals, and its therapeutic area is classified as Other.
Cesol is being studied for use in healthy individuals, as part of a bioequivalence study. The completed Phase 1 trial evaluated a coated tablet formulation of Cesol compared to Biltricide. The drug's therapeutic area is classified as Other, and it is not yet approved for any specific disease indication.
Cesol is developed by Merck KGaA, a pharmaceutical company. The company's stock ticker is MKGAF. Merck KGaA is conducting clinical trials to evaluate the drug's bioequivalence and pharmacokinetic properties in healthy volunteers.
Cesol is in Phase 1 clinical development. The drug has completed one Phase 1 trial, which involved 36 healthy male volunteers in Germany. The trial was a bioequivalence study comparing a coated tablet formulation of Cesol to Biltricide. Cesol is investigational and not yet approved.
Cesol has one completed clinical trial, NCT04314037, a Phase 1 bioequivalence study of coated Cesol tablet formulation versus Biltricide. The trial enrolled 36 healthy male volunteers aged 18 years and older in Germany. It was a controlled, randomized study, though not double-blind.
Cesol is not the same as Biltricide. In the completed clinical trial NCT04314037, Cesol was compared to Biltricide to assess bioequivalence. The study evaluated whether the coated tablet formulation of Cesol produces similar drug levels in the body as Biltricide.