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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02017236 | A Food Effect Phase I Study of the Volitinib in Healthy Subjects | PHASE1 | COMPLETED | 25 | — | — | Nov 1, 2013 | Jun 1, 2014 | May 14, 2019 | 1 | China |
The following PK parameters will be derived from the plasma concentration-time profile of Volitinib following administration:Area Under Curve (AUC), both from time zero to time with last observation and from time zero to infinity;;Maximum plasma concentration (Cmax);Time to reach the Cmax (Tmax);Apparent oral Clearance (CL/F);Apparent oral Volume of distribution (Vz/F);Other parameters, such as elimination half-life
| Arm | Type | Description |
|---|---|---|
| Volitinib ,after high fat meal intake | EXPERIMENTAL | A:single oral Volitinib after high fat meal intake |
| Volitinib,after general diet | EXPERIMENTAL | B:single oral Volitinib, after general diet |
| Name | Type | Description |
|---|---|---|
| Volitinib | DRUG | 600mg Volitinib ,single dose,oral |
Inclusion Criteria: * Males , between 18 and 45 years of age, inclusive. * Body mass index (BMI) within the range of 19 to 25 kg/m2, inclusive. * In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs. * Adequate hep...