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NOT YET RECRUITING
NCT07764692
PHASE1

A Phase I Clinical Trial to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-10504

Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a single-center, open-label, fixed-sequence, self-controlled Phase I clinical study with a planned enrollment of approximately 18 healthy participants.

Official title: A Phase I Clinical Trial to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-10504 in Healthy Participants

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2026-08-01

Completion Date

2027-03-31

Last Updated

2026-08-14

Healthy Volunteers

Yes

Interventions

DRUG

HS-10504

Participants will receive a single oral dose of 400 mg HS-10504 tablets on study days D1 and D15, respectively。

DRUG

Itraconazole Capsules

Participants will receive itraconazole capsules 0.2 g orally once daily from Day 11 to Day 23 for 13 consecutive days (with co-administration of itraconazole and HS-10504 on an empty stomach on Day 15)。