Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pletal · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Cilostazol 50 mg Tablets (Eon Pharma, LLC, USA) |
| 2 | ACTIVE_COMPARATOR | Pletal (Cilostazol) 50 mg Tablets (Otsuka Pharma Co, Ltd., USA) |
| Name | Type | Description |
|---|---|---|
| Cilostazol 50 mg Tablets (Eon Pharma, LLC, USA) | DRUG | - |
| Pletal (Cilostazol) 50 mg Tablets (Otsuka Pharma Co, Ltd., USA) | DRUG | - |
Inclusion Criteria: * No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: * Positive test results for HIV or hepatitis B or C. * Treatment for drug or alcohol dependence.
Pletal is a small molecule drug also known as cilostazol, supplied as 50 mg tablets. It has been studied in a Phase 1 clinical trial for pain. The trial, NCT00881231, was an active-controlled, randomized bioavailability study of cilostazol 50 mg tablets under fasting conditions.
Pletal has been investigated for pain. The only listed trial, NCT00881231, enrolled 26 healthy volunteers and evaluated the relative bioavailability of cilostazol 50 mg tablets under fasting conditions. The trial is completed, and no active trials are ongoing.
Pletal is associated with Novartis AG, ticker NVS. The drug is also identified as Pletal (Cilostazol) 50 mg Tablets (Otsuka Pharma Co, Ltd., USA). The listed developer for the clinical program is Novartis AG.
Pletal is in Phase 1 clinical development. The only listed trial, NCT00881231, is a completed Phase 1 bioavailability study. There are no active trials. Pletal is investigational and is not stated to be approved by the FDA.
Pletal has been studied in one clinical trial: NCT00881231, titled "To Demonstrate the Relative Bioavailability of Cilostazol 50 mg Tablets Under Fasting Conditions." It was a completed Phase 1 trial with 26 enrolled participants, randomized and active-controlled, in healthy volunteers.
Yes, Pletal is also known as cilostazol. The full alternative name is Pletal (Cilostazol) 50 mg Tablets (Otsuka Pharma Co, Ltd., USA). The trial NCT00881231 studied cilostazol 50 mg tablets, confirming that Pletal and cilostazol refer to the same drug.