Study on the Drug Interactions of HRS-9813, Pirfenidone and Nintedanib in Healthy Subjects

Sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
Study ID
NCT07229716
Phase
PHASE1
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • HRS-9813 Capsule — DRUG
    HRS-9813 capsule, specified dose on specified days.
  • Nintedanib Soft Capsules — DRUG
    Nintedanib soft capsules, specified dose on specified days.
  • Pirfenidone Tablets — DRUG
    Pirfenidone tablets, specified dose on specified days.

Study Details

This study aims to evaluate the interaction of oral HRS-9813 capsules with pirfenidone and nintedanib on the pharmacokinetics of healthy subjects.

Key Dates

Start date
Apr 4, 2026
Status verified
Apr 2026
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HRS-9813 Capsule or Nintedanib Soft Capsules or Pirfenidone Tablets Group

Primary Outcome Measure

The maximum plasma concentration (Cmax) [ Time Frame: From Day 1 to Day 24. ]

Central Contacts

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