NCT07229716 Study on the Drug Interactions of HRS-9813, Pirfenidone and Nintedanib in Healthy Subjects
| NCT ID | NCT07229716 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Guangdong Hengrui Pharmaceutical Co., Ltd |
| Condition | Pulmonary Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-04-04 |
| Primary Completion | 2026-05 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This study aims to evaluate the interaction of oral HRS-9813 capsules with pirfenidone and nintedanib on the pharmacokinetics of healthy subjects.
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily sign the informed consent form before the start of the related activities of this trial, and be able to understand the procedures and methods of this trial. Also, be willing to strictly follow the clinical trial protocol to complete this trial. 2. Aged 18-45 years. 3. Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19 - 28 kg/m2 (including both endpoints). 4. Sign the informed consent form and, within 28 days after the last administration of the trial drug, have no intention of having children and agree to adopt non-drug methods of effective contraception, and have no plans for sperm donation or egg donation. Exclusion Criteria: 1. Those who are allergic to the study drugs (HRS-9813 capsules, nintedanib or pirfenidone), or any components of the study drugs, or have an allergic constitution (such as individuals with asthma, allergic rhinitis, or eczema). 2. Those subjects who, in the judgment of the researchers, have any conditio