Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cilostazol · 2 trials · 1 indication
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Cilostazol (test) | EXPERIMENTAL | Cilostazol 50 mg Tablet (test) dosed in first period followed by Pletal® 50 mg Tablet (reference) dosed in second period |
| Pletal® (reference) | ACTIVE_COMPARATOR | Pletal® 50 mg Tablet (reference) dosed in first period followed by Cilostazol 50 mg Tablet (test) dosed in second period. |
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Cilostazol 50 mg Tablets | DRUG | 1 x 50 mg, single-dose fasting |
| Pletal® | DRUG | 1 x 50 mg, single-dose tablet |
| Cilostazol 100 mg tablets | DRUG | 1 x 100 mg |
| Pletal® 100 mg tablets | DRUG | 1 x 100 mg |
Inclusion Criteria: * Screening Demographics: All volunteers selected for this study will be healthy men or women 18 years of age or older at the time of dosing. The volunteer's body mass index (BMI) is less than or equal to 30. * Screening Procedures: Each volunteer will complete the screening pro...
Cilostazol is a small molecule drug developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. It is being studied in Phase 1 clinical development. The specific therapeutic indication for cilostazol has not been disclosed, and the program is categorized under a general therapeutic area rather than a named disease.
Cilostazol targets PDE3A, a phosphodiesterase enzyme. Cilostazol acts as an inhibitor of PDE3A. Inhibiting this target is the mechanism through which the drug is designed to exert its pharmacological effect. Cilostazol is a small molecule modality, and its target class is classified as an inhibitor.
Cilostazol is developed by Teva Pharmaceutical Industries Limited, which is listed under the ticker symbol TEVA. Teva is the company associated with the cilostazol program. The drug is a small molecule and is currently in Phase 1 development.
Cilostazol is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program includes two completed trials with a total enrollment of 66 participants. No active trials are currently listed for cilostazol.
Cilostazol has been studied in two completed Phase 1 trials. NCT00839930 evaluated cilostazol 50 mg tablets under fasting conditions in 30 healthy volunteers in the United States. NCT00838630 evaluated cilostazol 100 mg tablet formulations under fasting conditions in 36 healthy volunteers in the United States. Both trials enrolled adults aged 18 years and older.