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

NCT07134465 · Status: ENROLLING_BY_INVITATION · 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 Itraconazole on the pharmacokinetics of HSK31858 in healthy subjects

Conditions

  • Healthy Subjects

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,

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
2025-08-11
Primary Completion
2026-11-30
Completion
2026-11-30

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 NCT07134465 on ClinicalTrials.gov