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A Study to Estimate Effect of Formulation and Food on Relative Bioavailability of HRS-6209 in Healthy Participants
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
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
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
21
Start Date
2026-05
Completion Date
2026-06
Last Updated
2026-05-27
Healthy Volunteers
Yes
Conditions
Interventions
HRS-6209 Capsule (old formulation)
Oral administration after fasting.
HRS-6209 Capsule (new formulation)
Oral administration after fasting/high-fat meal.
Locations (1)
Fuzhou University Affiliated Provincial Hospital
Fuzhou, Fujian, China