None listed
Conditions
Interventions
patient group:Oral pirfenidone capsules 400mg 30min after a standard breakfast (non-high-fat, high-calorie, low-sugar)
Control group:Oral pirfenidone capsules 400mg 30min after a standard breakfast (non-high-fat, high-calorie, low-sugar)
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Patient group subjects must meet all of the following criteria for inclusion: (1) Patients with chronic kidney disease, both male and female; (2) Age 18-70 years old, including 18 years old and 70 years old; (3) Weight: males =50kg, females =45kg, 18=BMI=26 (BMI=weight (kg)/height 2 (m2)); (4) Chronic kidney disease stage is G2 or G3a, suggesting mild or moderate decrease in GFR, that is, glomerular filtration rate 45=eGFR(ml/min/1.73m2)=89 (calculated according to CKD-EPI formula) ; (5) Subjects who agree to quit smoking, alcohol, fruit juice drinks, caffeine, and tea from 24 hours before the start of the test to the end of the test; (6) Have a detailed understanding of the nature, significance, possible benefits, possible inconveniences and potential dangers of the trial before the study, and voluntarily participate in this clinical trial, can communicate well with the investigator, and comply with the requirements of the entire study, and Ability to understand and sign written informed consent. Control subjects must meet all of the following criteria for inclusion: (1) Gender: Chinese healthy subjects, both male and female; (2) Age 18-70 years old, including 18 years old and 70 years old; (3) Weight: males =50kg, females =45kg, 18=BMI=26 (BMI=weight (kg)/height 2 (m2)); (4) Subjects who agree to quit smoking, alcohol, fruit juice drinks, caffeine, and tea from 24 hours before the start of the test to the end of the test; (5) Have a detailed understanding of the nature, significance, possible benefits, possible inconveniences and potential dangers of the trial before the study, and voluntarily participate in this clinical trial, can communicate well with the investigator, and comply with the requirements of the entire study, and Those who have the ability to understand and sign the written informed consent form.
Exclusion criteria
Exclusion criteria: Subjects in the patient group who meet one of the following conditions will not be enrolled in this trial: (1) (Inquiry) Those who have participated in any other clinical trials within three months before the trial; (2) (Consultation) Any disease that may affect the safety of the test or the in vivo process of the drug, excluding chronic kidney disease, including but not limited to: heart, liver, digestive tract, immune system and respiratory system, etc. past or present Patients with the above systemic diseases (especially any gastrointestinal disease that affects drug absorption (such as irritable bowel syndrome symptoms, bowel disease or history of inflammatory bowel disease), active pathological bleeding (such as peptic ulcer), urticaria, Epilepsy, allergic rhinitis, eczematous dermatitis, asthma, etc.]; (3) (Inquiry) Allergic constitution: if there are two or more drugs, food allergy history (including test drugs), lactose intolerance; (4) (Inquiry) Have used any drugs that inhibit or induce liver metabolism of drugs within 28 days before taking the study drug (common liver enzyme inducers: barbiturates, carbamazepine, aminoglutamine, griseofulvin Inhibitors of liver enzymes: chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid, sulfa drugs); (5) (Inquiry) Those who cannot follow a unified diet (such as intolerance to standard meals, etc.) or have difficulty swallowing; (6) (Inquiry) Those who cannot tolerate venipuncture and/or have a history of haemorrhage or needle halo; (7) (Inquiry) Those who have long-term overdose (more than 8 cups a day, 1 cup = 250mL) tea, coffee or caffeinated beverages; or within 24 hours before the first dose of the study, ingested any caffeine-containing beverages Food or beverages (such as coffee, strong tea, chocolate, etc.) that affect the absorption, distribution, metabolism, and excretion of drugs and other special diets; (8) (Inquiry) Past alcoholism (i.e. drinking more than 28 standard units per week for men and more than 21 standard units per week for women (1 standard unit contains 14 g of alcohol, such as 360 mL of beer or 45 mL of alcohol for 40 % of spirits or 150 mL of wine); or frequent alcohol consumption (more than 14 standard units per week) within 6 months prior to the trial; or who took any alcoholic product within 24 hours before the first dose of the study; (9) (Inquiry) Those who have donated blood or massive bleeding (more than 450mL) within 3 months before the first administration of the study, or plan to donate blood or blood components during the study or within 3 months after the end of the study; (10) (Inquiry) Acute disease occurs during the pre-study screening phase or before the study drug; (11) (Inquiry) Those who have taken food or beverages that can induce or inhibit liver metabolic enzymes (such as grapefruit, mango, dragon fruit, grape juice, orange juice, etc. rich in flavonoids or citrus) within 24 hours before the first administration of the study glycosides); (12) (Inquiry) pregnant or breastfeeding women, and subjects (or their partners) who have a pregnancy plan during the trial and within 3 months after the end of the study, who do not agree to use non-drug measures for contraception during the trial; (13) (Inquiry) Those who have undergone surgery within three months before the screening period, or those who plan to undergo surgery during the study period, and those who have undergone surgery that will affect drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of pirfenidone in plasma by LC-MS/MS;Determination of pirfenidone in urine by LC-MS/MS; | — |
Countries
China
Contacts
Public ContactShaojun Shi
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed