A Pharmacokinetic and Bioequivalence Study of Savolitinib Tablets in Healthy Chinese Male Volunteers
- Sponsor
- Hutchison Medipharma Limited
- Study ID
- NCT03860948
- Phase
- PHASE1
- Status
- Completed
Conditions
- Bioequivalence
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - 40 Years
- Healthy Volunteers
- Accepted
Interventions
- Savolitinib Test Preparation — DRUGTest preparation (T): dry granulation savolitinib tablets.
- Savolitinib Reference Preparation — DRUGReference preparation (R): wet granulation savolitinib tablets.
Study Details
This is a single-center, randomized, open lebal, single-dose, three-period, crossover clinical study in healthy Chinese male subjects to assess the pharmacokinetics and bioequivalence/bioavailability of two formulation savolitinib tablets.
Key Dates
- Start date
- Apr 16, 2019
- Status verified
- Feb 2019
- Primary completion
- May 2, 2019
- Completion
- May 14, 2019
Study Design
- Enrollment
- 36 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Experimental: Savolitinib Test PreparationThe subjects in this arm will receive Test preparation (T). T is dry granulation savolitinib tablets.
- Experimental: Savolitinib Reference PreparationThe subjects in this arm will receive Reference preparation(R). R is wet granulation savolitinib tablets.
Primary Outcome Measure
The area under the curve(AUC) of savolitinib [ Time Frame: Measured on the Cycle1 Day1 to Day3, Cycle2 Day1 to Day3, Cycle3 Day1 to Day3, each cycle is 10 days. ]