A Clinical Study to Evaluate the Effect of Different Dosing Conditions on the Pharmacokinetics of HRS9531 Tablets in Healthy Participants

Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
Study ID
NCT06506175
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • HRS9531 tablets — DRUG
    HRS9531 tablets.

Study Details

The study is being conducted to evaluate the effects of different dosage regimen on the pharmacokinetics of HRS9531 tablets in healthy subjects.

Key Dates

First listed
Jul 17, 2024
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group A
    Different fasting time and dosing conditions.
  • Experimental: Treatment group B
    Different fasting time and dosing conditions.
  • Experimental: Treatment group C
    Different fasting time and dosing conditions.
  • Experimental: Treatment group D
    Different fasting time and dosing conditions.
  • Experimental: Treatment group E
    Different fasting time and dosing conditions.

Primary Outcome Measure

AUCtau [ Time Frame: 0-24 hours after the 10th dosing. ]

Central Contacts

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