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NOT YET RECRUITING
NCT07610148
PHASE1

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

Sponsor: Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

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

DRUG

HRS-6209 Capsule (old formulation)

Oral administration after fasting.

DRUG

HRS-6209 Capsule (new formulation)

Oral administration after fasting/high-fat meal.

Locations (1)

Fuzhou University Affiliated Provincial Hospital

Fuzhou, Fujian, China