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ENROLLING BY INVITATION
NCT07134465
PHASE1

Clinical Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HSK31858 in Healthy Subjects

Sponsor: Haisco Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a single-center, open-label, two-period, fixed-sequence clinical study to evaluate the effect of Itraconazole on the pharmacokinetics of HSK31858 in healthy subjects

Official title: A Single-center, Open-label, Two-period, Fixed-sequence Clinical Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HSK31858 in Healthy Subjects

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2025-08-11

Completion Date

2026-11-30

Last Updated

2025-12-31

Healthy Volunteers

Yes

Interventions

DRUG

HSK31858 Tablets and Itraconazole Capsules

HSK31858 Tablets On the morning of Day 1, a single dose of HSK31858 tablets 40 mg will be administered. Itraconazole capsules After a 10-day washout period, Take Itraconazole capsules 200mg in the morning and 200mg in the evening on D11 . A single dose of Itraconazole capsules 200 mg will be administered every morning from Day 12 to Day 14. On the morning of Day 15, take a single dose of itraconazole capsules 200mg, followed by a single dose of HSK31858 tablets 40 mg 1 hour later,

Locations (1)

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, China