Clinical Trial

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

Not Yet Recruiting Phase 1
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Record status
This record was last updated May 27, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
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).
Trial Details
NCT Number NCT07610148
Lead Sponsor Jiangsu HengRui Medicine Co., Ltd.
Conditions Breast Cancer
Enrollment 21 participants
Start Date 2026-05
Primary Completion 2026-06 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2026-05-27