Idiopathic pulmonary fibrosis
Conditions
Interventions
Group 1 :Using a two-cycle, self-crossover design, subjects used peak flow rates of 30 L/min or respectively according to the random results of dosing 60 L/min inhalation mode single oral inhalation o
Group 2:A two-period, self-crossover design was adopted. According to the random results of administration, the subjects inhaled 50 mg of HRG2101 inhalation by oral administration in two ways of activ
Group 3:Divided into two stages of single administration and multiple administration. In the single-dose phase, the subjects inhaled 100 mg HRG2101 inhalation orally once, and entered the multiple-dos
Group 4:Using a two-cycle, self-crossover design, subjects inhaled 200 mg orally in a single pass based on random dosing results HRG2101 inhalation or oral 200 mg pirfenidone tablets with a second cyc
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old, both male and female; 2. The weight of male subjects is >= 50.0 kg, the weight of female subjects is >= 45.0 kg, and the body mass index (BMI = weight (kg)/height 2 (m2)) is within the range of 19.0-26.0 kg/m2 (including the boundary value) ; 3. Fertile female subjects must undergo a serum pregnancy test within 7 days before the first medication and on the day of check-in, and the results are all negative. Fertile female subjects and male subjects whose partners are women of childbearing age must agree to abide by the contraceptive requirements from the signing of the informed consent until the end of the safety follow-up period (see Contraceptive methods in the appendix for details); 4. The subject can communicate well with the researcher, can use the powder aerosol device correctly after training, and can complete the research according to the researcher's requirements; 5. The subject fully understands the purpose, nature, method and possible adverse reactions of the test and voluntarily signs a written informed consent, and can complete the test in accordance with the protocol.
Exclusion criteria
Exclusion criteria: 1. Previously or currently suffering from any clinically serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities, which may affect the pharmacokinetics of the experimental drug as determined by the investigator medical characteristics or safety evaluators; 2. Those with a history of photosensitivity, those with skin abnormalities such as rash, itching, erythema, and eczema; 3. People with digestive system diseases such as loss of appetite, stomach discomfort, nausea, diarrhea, burning sensation in the chest, indigestion, or mental and nervous system diseases such as drowsiness, dizziness, and unsteady walking; 4. Currently suffering from oral diseases (such as oropharyngeal candida infection, oral ulcers, oral mucosal damage, etc.); 5. Those who have undergone major surgery within 3 months before screening, or those who have previously received surgery that may significantly affect the pharmacokinetic characteristics or safety evaluation of the investigational drug, or those who plan to undergo surgery during the study; 6. Those who are known to be allergic or intolerant to the test drug, test drug analogs and excipients, or have specific allergic diseases (such as allergic asthma, urticaria, eczema, etc.), or those with allergic constitution (such as to two or more drug, food or pollen allergies); 7. Any drug that inhibits or induces liver drug metabolism has been used within 1 month before the test (such as: inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines); 8. Subjects who have used any drugs (including prescription drugs, over-the-counter drugs, vitamin supplements or Chinese herbal medicines), health products or vaccines within 14 days before the test; 9. Subjects who have taken other clinical research drugs or used experimental devices within 3 months before the trial, or plan to participate in other clinical trials during this study; 10. Subjects who donated blood or lost a large amount of blood >= 400 mL (except for female physiological blood loss), received blood transfusion or used blood products within 3 months before the test, or planned to donate blood during the test or within 1 month after the end of the test; 11. Lactating women; 12. Those who drank excessive amounts of tea, coffee, grapefruit juice, and caffeinated beverages (more than 8 cups per day on average, 200 mL per cup) in the first 3 months of the test; 13. Those who have taken special diet (such as grapefruit, grapefruit juice or food/drink containing grapefruit juice, chocolate, tobacco, alcohol, caffeine and other food or drink) within 48 hours before the first administration; 14. The subject has a history of alcohol abuse within 6 months before the test, that is, the average weekly drinking of more than 14 units of alcohol (1 unit = 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine), or Those who cannot stop drinking during the test; 15. Subjects whose alcohol breath results are positive; 16. Subjects who smoked more than 5 cigarettes per day on average within 3 months before the test, or who could not quit smoking during the test, or who had a positive smoke test result; 17. The subject has a history of drug abuse or a positive d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration;physical examination;vital signs;laboratory test;12-lead electrocardiogram;adverse event; | — |
Countries
China
Contacts
Public ContactGuooing Yang
The Third Xiangya Hospital of Central South University
Outcome results
None listed