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 — DRUGHRS-9813 capsule, specified dose on specified days.
- Nintedanib Soft Capsules — DRUGNintedanib soft capsules, specified dose on specified days.
- Pirfenidone Tablets — DRUGPirfenidone 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
- Ruifang Guan+86-0518-82342973
- Ye Xu+86-0518-82342973
Related Studies
- Role of Genetic Factors in the Development of Lung DiseaseRecruiting · National Heart, Lung, and Blood Institute (NHLBI) · Bethesda, Maryland
- Genetic Polymorphisms in Idiopathic Pulmonary Fibrosis (IPF)Recruiting · University of Pittsburgh · Pittsburgh, Pennsylvania
- Explanted Lung Tissues With Pulmonary FibrosisRecruiting · University of Chicago · Chicago, Illinois
- Preliminary Evaluation of [68Ga]CBP8 in Healthy Individuals, Lung Cancer, and Idiopathic Pulmonary Fibrosis PatientsPHASE1 · Recruiting · Massachusetts General Hospital · Boston, Massachusetts