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 being studied in healthy volunteers. It is currently in Phase 1 clinical development, with two completed trials evaluating different tablet formulations under fasting conditions. The drug is being developed by Teva Pharmaceutical Industries Limited.
Cilostazol is being developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker TEVA. The drug is currently in Phase 1 clinical development, with two completed trials in healthy volunteers.
Cilostazol is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers. The trials studied 100 mg and 50 mg tablet formulations under fasting conditions. The drug is not yet approved and remains investigational.
Cilostazol has two completed Phase 1 clinical trials. NCT00838630 studied 100 mg tablet formulations under fasting conditions with 36 participants. NCT00839930 studied 50 mg tablets under fasting conditions with 30 participants. Both trials were conducted in the United States with healthy volunteers aged 18 years and older.
Cilostazol is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. Two Phase 1 trials have been completed in healthy volunteers, but the drug has not yet received regulatory approval.