Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Savolitinib Test Preparation · 1 trial · 1 indication
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...
Savolitinib Test Preparation is an investigational small molecule developed by HUTCHMED (China) Limited. It is a tablet formulation studied in a Phase 1 pharmacokinetic and bioequivalence trial in healthy Chinese male volunteers. The specific disease indications for this preparation have not been disclosed.
Savolitinib Test Preparation targets MET, a receptor tyrosine kinase. It is classified as an inhibitor, meaning it is designed to block MET activity. The completed Phase 1 trial evaluated the pharmacokinetics and bioequivalence of the tablet formulation rather than measuring efficacy against a disease.
Savolitinib Test Preparation is developed by HUTCHMED (China) Limited, which trades under the ticker HCM. The company sponsored the Phase 1 pharmacokinetic and bioequivalence study of the tablet formulation conducted in China.
Savolitinib Test Preparation is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The single recorded trial, NCT03860948, is a completed Phase 1 pharmacokinetic and bioequivalence study of the tablet formulation in healthy Chinese male volunteers.
Savolitinib Test Preparation has been studied in one clinical trial, NCT03860948, titled A Pharmacokinetic and Bioequivalence Study of Savolitinib Tablets in Healthy Chinese Male Volunteers. The Phase 1 trial was completed, enrolled 36 participants, used a controlled design, and was conducted in China.