drugset / Trial / NCT07610148

A Study to Estimate Effect of Formulation and Food on Relative Bioavailability of HRS-6209 in Healthy Participants

NCT07610148

Phase 1 Not yet recruiting 21 enrolled Jiangsu HengRui Medicine Co., Ltd.
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

EvaluationDrugModalityDoseRoute
Subject HRS-6209 Small molecule Oral

Indications