drugset / Trial / NCT06694948
A Study to Evaluate the Relative Bioavailability of Two Different Pimicotinib Capsules in Healthy Subjects
RandomizedCrossoverOpen-labelOther
Summary
This is a study to evaluate the relative bioavailability and tolerability of two different pimicotinib capsules in healthy subjects under fasting condition. 26 healthy subjects are planned to be enrolled and will be evenly randomized to either Study Sequence A or Study Sequence B . Subjects in Sequence A/Sequence B will receive a single 50 mg oral dose of test/reference pimicotinib in period 1 and cross over in period 2. Blood samples will be collected for PK analysis in totally 32 time-points.
Timeline
- Start
- 2024-12-10
- Primary completion
- 2025-01-03
- Completion
- 2025-01-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pimicotinib | Small molecule | 50 mg | Oral |
Indications
No indication recorded.