OncRef

Clinical Trial: NCT07610148

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 1

Lead Sponsor:Jiangsu HengRui Medicine Co., Ltd.
Information Provided By:Jiangsu HengRui Medicine Co., Ltd.
Last Update Posted:2026-08-25

Study Overview

Brief 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).

Official Title

A Single-Center, Single-Dose, Randomized, Open-Label, Three-Period, Three-Sequence, Crossover Study to Evaluate the Oral Relative Bioavailability of Old and New Formulations of HRS-6209 Capsules and the Effect of Food in Healthy Chinese Participants

Conditions

Breast Cancer

Intervention / Treatment

  • Drug: HRS-6209 Capsule (old formulation)
  • Drug: HRS-6209 Capsule (new formulation)

Other Study ID Numbers

  • HRS-6209-102

Start Date (Actual)

2026-06-08

Primary Completion Date (Estimated)

2026-09

Study Completion Date (Estimated)

2026-09

Enrollment (Actual)

21

Study Type

Interventional

Phase

Phase 1