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

NCT07134478 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-12-31

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-28
Primary Completion
2024-12-24
Completion
2026-06-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07134478 on ClinicalTrials.gov