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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03860948 | A Pharmacokinetic and Bioequivalence Study of Savolitinib Tablets in Healthy Chinese Male Volunteers | PHASE1 | COMPLETED | 36 | — | — | Apr 16, 2019 | May 14, 2019 | May 16, 2019 | 1 | China |
The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration.
Maximum observed concentration, occurring at Tmax.
The time at which maximum plasma concentration (Cmax) is observed.
The time required for the concentration of the drug to reach half of its original value.
A term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug.
| Arm | Type | Description |
|---|---|---|
| Savolitinib Test Preparation | EXPERIMENTAL | The subjects in this arm will receive Test preparation (T). T is dry granulation savolitinib tablets. |
| Savolitinib Reference Preparation | EXPERIMENTAL | The subjects in this arm will receive Reference preparation(R). R is wet granulation savolitinib tablets. |
| Name | Type | Description |
|---|---|---|
| Savolitinib Test Preparation | DRUG | Test preparation (T): dry granulation savolitinib tablets. |
| Savolitinib Reference Preparation | DRUG | Reference preparation (R): wet granulation savolitinib tablets. |
Inclusion Criteria: 1. Subjects must agree to comply with the protocol and Informed consent must be obtained in writing for all subjects; 2. Healthy male subjects aged 18 to 45 years inclusive at the time of screening; 3. Weight ≥ 50 kg, body mass index (BMI) of 19-26 kg/m2; 4. No clinically signif...