Actively Recruiting
Study on the Drug Interactions of HRS-9813, Pirfenidone and Nintedanib in Healthy Subjects
Led by Guangdong Hengrui Pharmaceutical Co., Ltd · Updated on 2026-04-27
20
Participants Needed
1
Research Sites
3 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the interaction of oral HRS-9813 capsules with pirfenidone and nintedanib on the pharmacokinetics of healthy subjects.
CONDITIONS
Official Title
Study on the Drug Interactions of HRS-9813, Pirfenidone and Nintedanib in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign informed consent and understand the trial procedures
- Aged 18 to 45 years
- Male weight at least 50 kg, female weight at least 45 kg, BMI between 19 and 28 kg/m2
- Agree to use effective non-drug contraception and avoid sperm or egg donation during the trial and for 28 days after last drug administration
You will not qualify if you...
- Allergy to HRS-9813 capsules, nintedanib, pirfenidone, or any components
- Conditions affecting absorption, metabolism, or excretion of study drugs
- Participation in other clinical trials or exposure to investigational drugs within 3 months before screening
- Sitting systolic blood pressure below 90 mmHg or diastolic below 60 mmHg during screening
- Positive for hepatitis B surface antigen, HIV antibody, Treponema pallidum antibody, or hepatitis C antibody during screening
- Pregnant or lactating women, or positive pregnancy test at screening
- History of blood donation within 8 weeks or severe blood loss (≥400 mL), or blood transfusion within 4 weeks before screening
- Vaccination within 2 weeks before screening or planned vaccination during study
- Special dietary requirements preventing uniform diet
- Difficulty swallowing or problems with blood collection
- Severe infection, trauma, or major surgery within 3 months before screening or planned surgery during study
- Abnormal electrocardiogram with QTcB >450 ms for men or >460 ms for women
- History of smoking more than 5 cigarettes daily within 3 months or smoking within 4 weeks before screening
- History of drug abuse or positive urine drug test at baseline
- Consumption of more than 8 cups of tea, coffee, or caffeinated beverages daily within 6 months before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tangdu Hospital, Fourth Military Medical University
Xi’an, Shanxi, China, 710026
Actively Recruiting
Research Team
R
Ruifang Guan
CONTACT
Y
Ye Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here