Idiopathic pulmonary fibrosis
Conditions
Interventions
Experimental group:Ifenidone (20 mg50 mg100 mg200 mg400 mg 600 mg800 mg)
Control group:Placebo
Sponsors
Phase I Clinical Research Centre, Shanghai Xuihui Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1) Volunteer to participate in the experiment, able to understand and sign informed consent forms, and able to complete the experiment according to the requirements of the experimental plan; 2) Willing to voluntarily take effective contraceptive measures during the trial period and within 3 months after administration, without any pregnancy plans; 3) When signing informed consent, the age range is 18 to 55 years old, regardless of gender (including 18 and 55 years old); 4) Male weight = 50 kg, female weight = 45 kg, and body mass index (BMI) within the range of 18-28 kg/m^2 (including critical values); 5) Individuals confirmed to be in good health condition through medical history inquiry, physical examination, vital signs examination, electrocardiogram examination, laboratory examination, and chest X-ray examination.
Exclusion criteria
Exclusion criteria: 1)Individuals with serum creatinine, ALT, and AST levels = 1.5 times the upper limit of normal values during the screening period. 2) When screening, hepatitis B surface antigen, hepatitis C antibody, HIV antibody or treponema pallidum antibody were positive. 3) Screening for gastrointestinal diseases that can affect drug absorption or metabolism within the first 6 months (excluding those who are cured or not); Individuals with a history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system (such as thymic disease), and reproductive system (such as prostate, testis, epididymis, and ovarian disease); And/or those who have thyroid diseases or have previously undergone thyroid surgery, malignant tumors, metabolic disorders, or other diseases that are not suitable for clinical trials (such as a history of mental illness). 4) Individuals with a history of allergies or allergies to the test product, any of its components, or related preparations are known. 5) Any prescription or over-the-counter medication taken within 14 days prior to the start of the study drug, or any medication that inhibits or induces liver metabolism within 28 days, such as inducers - barbiturates, glumether, rifampicin, carbamazepine, phenytoin, omeprazole, griseofulvin, trimethoprim, etc.; inhibitors - macrolide antibiotics (such as erythromycin, clarithromycin, etc.), azole antifungal drugs (such as ketoconazole, itraconazole, etc.), fluoroquinolones (such as ciprofloxacin, etc.), calcium channel blockers (such as verapamil, diltiazem, etc.), H1 receptors Antagonists (such as aspirin), H2 receptor antagonists (such as cimetidine), SSRI antidepressants (such as fluoxetine, fluvoxamine, etc.), benzodiazepines, HMG CoA reductase inhibitors (such as lovastatin, simvastatin, etc.), nitroimidazoles, etc. 6) Consumed foods or beverages containing caffeine, xanthine, alcohol, or grapefruit within 48 hours prior to taking the study medication. 7) Drug abuse tests (morphine, tetrahydrocannabidiol acid, methamphetamine, dimethylenedioxymethamphetamine, ketamine, and cocaine) and positive alcohol breath tests. 8) Smokers, alcoholics, or other people who cannot ban smoking or alcohol during the test period (defined as smoking = 10 cigarettes a day, alcoholism as drinking at least twice a day or more than 14 times a week, alcoholism as drinking 5 or more times in about 2 hours; and once drinking as 125 mL of wine, 220 mL of beer, or 50 mL of Baijiu). 9) Donate blood or lose more than 500 mL of blood within 28 days prior to taking the investigational medication. 10) Those who plan to undergo organ transplantation or have already undergone organ transplantation. 11) Breastfeeding or pregnant women. 12) Pregnancy test positive for women of childbearing age. 13) Individuals who have participated in clinical trials of other drugs within the first three months of selection. 14) The researchers believe that subjects with other unsuitable factors for participating in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of Ifenidone;The max Concentration;The Area Under Concentration;Tmax;t1/2;MRT;CL/F;VZ/F;Kel; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety indicators; | — |
Countries
China
Contacts
Public ContactYanmei Liu
Shanghai Xuihui Central Hospital
Outcome results
None listed