Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00839930 | Cilostazol 50 mg Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 30 | — | — | Feb 1, 2004 | Feb 1, 2004 | Aug 20, 2024 | 2 | United States |
| NCT00838630 | Cilostazol 100 mg Tablet Formulations Under Fasting Conditions | PHASE1 | COMPLETED | 36 | — | — | Nov 1, 2003 | Nov 1, 2003 | Aug 19, 2024 | 1 | United States |
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...