NCT07134465

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

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

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
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,

Timeline

• Start date: 2025-08-11
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2025-08-21
• Last updated: 2025-12-31

Locations

1 site across 1 country: China