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 used for bioequivalence testing. It is a small molecule drug being studied in healthy Chinese male volunteers to compare the pharmacokinetics of savolitinib tablets. The drug is in Phase 1 clinical development and is not yet approved for any indication.
Savolitinib Test Preparation is developed by HUTCHMED (China) Limited, a biopharmaceutical company listed on the stock exchange under the ticker HCM. The company is conducting clinical trials to evaluate the drug's bioequivalence in healthy volunteers.
Savolitinib Test Preparation is in Phase 1 clinical development. It is an investigational drug being studied for bioequivalence purposes. The drug has received FDA designations including Breakthrough Therapy, Fast Track, and Priority Review, but it is not yet approved for any medical use.
Savolitinib Test Preparation is being studied in one completed clinical trial, NCT03860948, titled 'A Pharmacokinetic and Bioequivalence Study of Savolitinib Tablets in Healthy Chinese Male Volunteers.' This Phase 1 trial enrolled 36 healthy male participants in China and was a randomized, controlled study.
Savolitinib Test Preparation is a formulation of savolitinib used for bioequivalence testing. The clinical trial NCT03860948 compares savolitinib tablets to evaluate their pharmacokinetic equivalence. The drug is being developed by HUTCHMED (China) Limited under the ticker HCM.