This study aims to evaluate the interaction of oral HRS-9813 capsules with pirfenidone and nintedanib on the pharmacokinetics of healthy subjects.
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.
Aged 18-45 years.
Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19 - 28 kg/m2 (including both endpoints).
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.
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).
Those subjects who, in the judgment of the researchers, have any conditions or diseases that may affect the absorption, metabolism, and/or excretion of the study drug.
Those who participated in any clinical trial of other drugs or medical devices within the previous 3 months before the screening period or baseline period, or those whose exposure to the drug is still within 5 half-lives during the study period (whichever is longer).
During the screening period or baseline period, the sitting systolic blood pressure was less than 90 mmHg or the sitting diastolic blood pressure was less than 60 mmHg.
Single group
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.
The maximum plasma concentration (Cmax)
Area under the concentration curve from time 0 to extrapolated infinite time (AUC0-inf)
Area under the concentration curve from time 0 to time of last quantifiable concentration (AUC0-tau)
Area under the concentration curve from time 0 to time t (AUC0-t)
Accumulative excretion rate (Ae)
Fractional excretion (Fe)
Renal clearance (CLr)
Adverse events (AEs)
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