A Trial of HRS-9813 Capsule and Tablet in Healthy Subjects

Sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
Study ID
NCT06939504
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

Study Details

This is a phase Ⅰ study to evaluate the relative bioavailability of HRS-9813 capsule and tablet in healthy subjects and the effect of food on the pharmacokinetics of HRS-9813 capsule.

Key Dates

First listed
Apr 22, 2025
Start date
May 4, 2025
Status verified
Jul 2025
Primary completion
Jun 3, 2025
Completion
Jun 23, 2025

Study Design

Enrollment
12 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: HRS-9813 Capsule Group
  • Experimental: HRS-9813 Tablet Group

Primary Outcome Measure

Maximum observed concentration of HRS-9813 capsule (Cmax) [ Time Frame: Day 1-Day 23. ]

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