renal insufficiency
Conditions
Interventions
Experimental group and control group:parallel control
Sponsors
Phase I clinical study room of The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Men and women aged 65-80 years. Healthy volunteers matched with subjects with renal insufficiency patients on age (+/-5 years), gender, weight, and renal function status; (2) Male weight = 50 kg, female = 45 kg; BMI 18 to 26; (3) renal insufficiency patients: creatinine clearance 80mL/min; (4) All subjects agreed to break away from smoke, alcohol, caffeine, and fruit juice from 48h before the study to the end of the trial; (5) Capable of providing written informed consent.;Inclusion criteria: (1) Men and women aged 65-80 years. Healthy volunteers matched with subjects with renal insufficiency patients on age (+/-5 years), gender, weight, and renal function status; (2) Male weight = 50 kg, female = 45 kg; BMI 18 to 26; (3) renal insufficiency patients: creatinine clearance 80mL/min; (4) All subjects agreed to break away from smoke, alcohol, caffeine, and fruit juice from 48h before the study to the end of the trial; (5) Capable of providing written informed consent.;Inclusion criteria: (1) Men and women aged 65-80 years. Healthy volunteers matched with subjects with renal insufficiency patients on age (+/-5 years), gender, weight, and renal function status; (2) Male weight = 50 kg, female = 45 kg; BMI 18 to 26; (3) renal insufficiency patients: creatinine clearance 80mL/min; (4) All subjects agreed to break away from smoke, alcohol, caffeine, and fruit juice from 48h before the study to the end of the trial; (5) Capable of providing written informed consent.;Inclusion criteria: (1) Men and women aged 65-80 years. Healthy volunteers matched with subjects with renal insufficiency patients on age (+/-5 years), gender, weight, and renal function status; (2) Male weight = 50 kg, female = 45 kg; BMI 18 to 26; (3) renal insufficiency patients: creatinine clearance 80mL/min; (4) All subjects agreed to break away from smoke, alcohol, caffeine, and fruit juice from 48h before the study to the end of the trial; (5) Capable of providing written informed consent.;Inclusion criteria: (1) Men and women aged 65-80 years. Healthy volunteers matched with subjects with renal insufficiency patients on age (+/-5 years), gender, weight, and renal function status; (2) Male weight = 50 kg, female = 45 kg; BMI 18 to 26; (3) renal insufficiency patients: creatinine clearance 80mL/min; (4) All subjects agreed to break away from smoke, alcohol, caffeine, and fruit juice from 48h before the study to the end of the trial; (5) Capable of providing written informed consent.
Exclusion criteria
Exclusion criteria: Renal insufficiency patients: 1) Known or suspected of allergy or allergies for sulfonamides, non-steroidal anti-inflammatory; 2) In addition to the diagnosis of renal insufficiency, complicated with any other acute organs diseases and chronic diseases which can influence process of the drug metablism; 3) In addition to the diagnosis of renal insufficiency, other clinically significant laboratory abnormalities (Note: moderate to severe anemia patients (Hb 180mmHg and / or diastolic blood pressure> 110mmHg) and patients with diabetic nephropathy; 4) Complicated with cardiovascular, neuropsychiatric, gastrointestinal, respiratory, endocrine and other serious illness history 1 year before launching of the trial; 5) Alcoholism, smoking addiction (=5 per day for 3 months), drug abuse; 6) Participants who participated in other drug tests within three months prior to started of the trial or who have used drugs may impaires the kidney; 7) 30 days before the start of the test, volunteer who use the liver metabolic enzyme function drug, or during the trial need to use other drugs may affect the absorption, distribution, metabolism, excretion of drugs; the exclusion will be determined by the researchers; 8) Women who are pregnant or lactating, or who cannot take 1 or more contraceptives during the trial; 9) Any one of following items shows positive: HBV surface antigen, HCV and HIV antibody. Healthy volunteers: 1) Known or suspected of sulfonamides, non-steroidal anti-inflammatory allergy or allergies; 2) Alcoholism, smoking addiction (=5 per day for 3 months), drug abuse; 3) Participated in other drug trials within three months of enrollment; 4) have chronic cardiovascular, neuropsychiatric, gastrointestinal, respiratory, urinary, endocrine and other system history; 5) in past 30 days previous the trial, used liver metabolic enzymes function drugs, or during the trial need to use other drugs may affect the absorption, distribution, metabolism, excretion of drugs; 6) Use of other drugs for the prevention or treatment of drugs; 7) Male / female volunteers who planing to pregnancy, or during pregnancy, breastfeeding, and unwilling or unable to take effective contraceptive measures during the trial; 8) HBV surface antigen, HCV, HIV antibody, anyone item to be found positive.;Exclusion criteria: Renal insufficiency patients: 1) Known or suspected of allergy or allergies for sulfonamides, non-steroidal anti-inflammatory; 2) In addition to the diagnosis of renal insufficiency, complicated with any other acute organs diseases and chronic diseases which can influence process of the drug metablism; 3) In addition to the diagnosis of renal insufficiency, other clinically significant laboratory abnormalities (Note: moderate to severe anemia patients (Hb 180mmHg and / or diastolic blood pressure> 110mmHg) and patients with diabetic nephropathy; 4) Complicated with cardiovascular, neuropsychiatric, gastrointestinal, respiratory, endocrine and other serious illness history 1 year before launching of the trial; 5) Alcoholism, smoking addiction (=5 per day for 3 months), drug abuse; 6) Participants who participated in other drug tests within three months prior to started of the trial or who have used drugs may impaires the kidney; 7) 30 days before the start of the test, volunteer who use the liver metabolic enzyme function drug, or during the trial need to use other drugs may affect the absorption, distribution, metabolism, excretion of drugs; the exclusion will be determined by the researchers; 8) Women who are pregnant or lactating, or who cannot take 1 or more contraceptives during the trial; 9) Any one of following items shows positive: HBV surface antigen, HCV and HIV antibody. Healthy volunteers: 1) Known or suspected of sulfonamides, non-steroidal anti-inflammatory allergy or allergies; 2) Alcoholism, smoking addiction (=5 per day for 3 months), drug abuse; 3) Participated in other drug trials within three months of enrollment; 4) have chronic cardiovascular, neuropsychiatric, gastrointestinal, respiratory, urinary, endocrine and other system history; 5) in past 30 days previous the trial, used liver metabolic enzymes function drugs, or during the trial need to use other drugs may affect the absorption, distribution, metabolism, excretion of drugs; 6) Use of other drugs for the prevention or treatment of drugs; 7) Male / female volunteers who planing to pregnancy, or during pregnancy, breastfeeding, and unwilling or unable to take effective contraceptive measures during the trial; 8) HBV surface antigen, HCV, HIV antibody, anyone item to be found positive.;Exclusion criteria: Renal insufficiency patients: 1) Known or suspected of allergy or allergies for sulfonamides, non-steroidal anti-inflammatory; 2) In addition to the diagnosis of renal insufficiency, complicated with any other acute organs diseases and chronic diseases which can influence process of the drug metablism; 3) In addition to the diagnosis of renal insufficiency, other clinically significant laboratory abnormalities (Note: moderate to severe anemia patients (Hb 180mmHg and / or diastolic blood pressure> 110mmHg) and patients with diabetic nephropathy; 4) Complicated with cardiovascular, neuropsychiatric, gastrointestinal, respiratory, endocrine and other serious illness history 1 year before launching of the trial; 5) Alcoholism, smoking addiction (=5 per day for 3 months), drug abuse; 6) Participants who participated in other drug tests within three months prior to started of the trial or who have used drugs may impaires the kidney; 7) 30 days before the start of the test, volunteer who use the liver metabolic enzyme function drug, or during the trial need to use other drugs may affect the absorption, distribution, metabolism, excretion of drugs; the exclusion will be determined by the researchers; 8) Women who are pregnant or lactating, or who cannot take 1 or more contraceptives during the trial; 9) Any one of following items shows positive: HBV surface antigen, HCV and HIV antibody. Healthy volunteers: 1) Known or suspected of sulfonamides, non-steroidal anti-inflammatory allergy or allergies; 2) Alcoholism, smoking addiction (=5 per day for 3 months), drug abuse; 3) Participated in other drug trials within three months of enrollment; 4) have chronic cardiovascular, neuropsychiatric, gastrointestinal, respiratory, urinary, endocrine and other system history; 5) in past 30 days previous the trial, used liver metabolic enzymes function drugs, or during the trial need to use other drugs may affect the absorption, distribution, metabolism, excretion of drugs; 6) Use of other drugs for the prevention or treatment of drugs; 7) Male / female volunteers who planing to pregnancy, or during pregnancy, breastfeeding, and unwilling or unable to take effective contraceptive measures during the trial; 8) HBV surface antigen, HCV, HIV antibody, anyone item to be found positive.;Exclusion criteria: Renal insufficiency patients: 1) Known or suspected of allergy or allergies for sulfonamides, non-steroidal anti-inflammatory; 2) In addition to the diagnosis of renal insufficiency, complicated with any other acute organs diseases and chronic diseases which can influence process of the drug metablism; 3) In addition to the diagnosis of renal insufficiency, other clinically significant laboratory abnormalities (Note: moderate to severe anemia patients (Hb 180mmHg and / or diastolic blood pressure> 110mmHg) and patients with diabetic nephropathy; 4) Complicated with cardiovascular, neuropsychiatric, gastrointestinal, respiratory, endocrine and other serious illness history 1 year before launching of the trial; 5) Alcoholism, smoking addiction (=5 per day for 3 months), drug abuse; 6) Participants who participated in other drug tests within three months prior to started of the trial or who have used drugs may impaires the kidney; 7) 30 days before the start of the test, volunteer who use the liver metabolic enzyme function drug, or during the trial need to use other drugs may affect the absorption, distribution, metabolism, excretion of drugs; the exclusion will be determined by the researchers; 8) Women who are pregnant or lactating, or who cannot take 1 or more contraceptives during the trial; 9) Any one of following items shows positive: HBV surface antigen, HCV and HIV antibody. Healthy volunteers: 1) Known or suspected of sulfonamides, non-steroidal anti-inflammatory allergy or allergies; 2) Alcoholism, smoking addiction (=5 per day for 3 months), drug abuse; 3) Participated in other drug trials within three months of enrollment; 4) have chronic cardiovascular, neuropsychiatric, gastrointestinal, respiratory, urinary, endocrine and other system history; 5) in past 30 days previous the trial, used liver metabolic enzymes function drugs, or during the trial need to use other drugs may affect the absorption, distribution, metabolism, excretion of drugs; 6) Use of other drugs for the prevention or treatment of drugs; 7) Male / female volunteers who planing to pregnancy, or during pregnancy, breastfeeding, and unwilling or unable to take effective contraceptive measures during the trial; 8) HBV surface antigen, HCV, HIV antibody, anyone item to be found positive.;Exclusion criteria: Renal insufficiency patients: 1) Known or suspected of allergy or allergies for sulfonamides, non-steroidal anti-inflammatory; 2) In addition to the diagnosis of renal insufficiency, complicated with any other acute organs diseases and chronic diseases which can influence process of the drug metablism; 3) In addition to the diagnosis of renal insufficiency, other clinically significant laboratory abnormalities (Note: moderate to severe anemia patients (Hb 180mmHg and / or diastolic blood pressure> 110mmHg) and patients with diabetic nephropathy; 4) Complicated with cardiovascular, neuropsychiatric, gastrointestinal, respiratory, endocrine and other serious illness history 1 year before launching of the trial; 5) Alcoholism, smoking addiction (=5 per day for 3 months), drug abuse; 6) Participants who participated in other drug tests within three months prior to started of the trial or who have used drugs may impaires the kidney; 7) 30 days before the start of the test, volunteer who use the liver metabolic enzyme function drug, or during the trial need to use other drugs may affect the absorption, distribution, metabolism, excretion of drugs; the exclusion will be determined by the researchers; 8) Women who are pregnant or lactating, or who cannot take 1 or more contraceptives during the trial; 9) Any one of following items shows positive: HBV surface antigen, HCV and HIV antibody. Healthy volunteers: 1) Known or suspected of sulfonamides, non-steroidal anti-inflammatory allergy or allergies; 2) Alcoholism, smoking addiction (=5 per day for 3 months), drug abuse; 3) Participated in other drug trials within three months of enrollment; 4) have chronic cardiovascular, neuropsychiatric, gastrointestinal, respiratory, urinary, endocrine and other system history; 5) in past 30 days previous the trial, used liver metabolic enzymes function drugs, or during the trial need to use other drugs may affect the absorption, distribution, metabolism, excretion of drugs; 6) Use of other drugs for the prevention or treatment of drugs; 7) Male / female volunteers who planing to pregnancy, or during pregnancy, breastfeeding, and unwilling or unable to take effective contraceptive measures during the trial; 8) HBV surface antigen, HCV, HIV antibody, anyone item to be found positive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration;Urine concentration; | — |
Countries
China
Contacts
Public ContactGuoping Yang;Guoping Yang;Guoping Yang;Guoping Yang;Guoping Yang ;;;;
The Third Xiangya Hospital of Central South University;The Third Xiangya Hospital of Central South University;The Third Xiangya Hospital of Central South University;The Third Xiangya Hospital of Central South University;The Third Xiangya Hospital of Central South University
Outcome results
None listed