Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cilostazol · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Cilostazol Tablets 100 mg |
| 2 | ACTIVE_COMPARATOR | Pletal® Tablets 100 mg |
| Name | Type | Description |
|---|---|---|
| Cilostazol Tablets 100 mg | DRUG | 100mg, single dose fasting |
| Pletal® Tablets 100 mg | DRUG | 100 single dose fasting |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the ev...
Cilostazol is a small molecule drug being studied in healthy volunteers. In clinical trials, it is used to evaluate the pharmacokinetics and bioequivalence of different formulations of the drug. The completed Phase 1 trial enrolled 44 healthy participants to compare Cilostazol tablets 100 mg with Pletal tablets 100 mg.
Cilostazol is a small molecule drug. The specific molecular target of Cilostazol is not provided in the available information. Therefore, its mechanism of action is not described here.
Cilostazol is being developed by Viatris Inc., a company traded on the stock exchange under the ticker VTRS. Viatris is the developer of this drug, which is currently in Phase 1 clinical development for healthy volunteers.
Cilostazol is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The drug has completed one Phase 1 trial, which was a fasting study comparing Cilostazol tablets 100 mg with Pletal tablets 100 mg.
Cilostazol has one completed clinical trial with the identifier NCT00648388. This Phase 1 study was a fasting study of Cilostazol tablets 100 mg and Pletal tablets 100 mg, conducted in the United States with 44 healthy participants aged 18 years and older.
Cilostazol is not the same as Pletal. In the clinical trial NCT00648388, Cilostazol tablets 100 mg were compared with Pletal tablets 100 mg as a reference drug. The study was designed to evaluate the bioequivalence between the two products, indicating they are distinct formulations.