drugset / Trial / NCT07610148
A Study to Estimate Effect of Formulation and Food on Relative Bioavailability of HRS-6209 in Healthy Participants
RandomizedCrossoverOpen-labelTreatment
Summary
This is a phase 1, randomised, open-label, three-way, three-period, crossover relative bioavailability study to assess the pharmacokinetics of HRS-6209 capsules (old and new formulation) in healthy participants. The effect of high-fat food on the pharmacokinetics of HRS-6209 in new formulation will also be evaluated. A total of 21 healthy participants will be randomised to receive a single oral dose of HRS-6209 in three treatment periods: old formulation (fasted); new formulation (fasted); new formulation (fasted).
Timeline
- Start
- 2026-05
- Primary completion
- 2026-06
- Completion
- 2026-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HRS-6209 | Small molecule | — | Oral |