NCT07134478

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• 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 Rifampicin on the pharmacokinetics of HSK31858 in healthy subjects

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	HSK31858 Tablets On the morning of Day 1, a single dose of HSK31858 tablets 40 mg will be administered. Rifampicin capsules After a 5-day washout period, a single dose of rifampicin capsules 600 mg wi	HSK31858 Tablets On the morning of Day 1, a single dose of HSK31858 tablets 40 mg will be administered. Rifampicin capsules After a 5-day washout period, a single dose of rifampicin capsules 600 mg will be administered every morning from Day 6 to Day 14. On the morning of Day 15, rifampicin capsules 600 mg and HSK31858 tablets 40 mg will be co-administered.

Timeline

• Start date: 2024-10-28
• Primary completion: 2024-12-24
• Completion: 2026-06-01
• First posted: 2025-08-21
• Last updated: 2025-12-31

Locations

1 site across 1 country: China