None listed
Conditions
Interventions
Test group and control group:Fasting or postprandial administration
Sponsors
Phase I Clinical Study Institute, The Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Male and Female aged 18 to 45 years old; 2. Weight= 50 kg, BMI 19to 24; 3. Valuntery and be able to sign informed consent; 4. The volunteer is able to communicate well with the investigator and be able to complete the study in accordance with the study protocol.;Inclusion criteria: 1. Male and Female aged 18 to 45 years old; 2. Weight= 50 kg, BMI 19to 24; 3. Valuntery and be able to sign informed consent; 4. The volunteer is able to communicate well with the investigator and be able to complete the study in accordance with the study protocol.;Inclusion criteria: 1. Male and Female aged 18 to 45 years old; 2. Weight= 50 kg, BMI 19to 24; 3. Valuntery and be able to sign informed consent; 4. The volunteer is able to communicate well with the investigator and be able to complete the study in accordance with the study protocol.;Inclusion criteria: 1. Male and Female aged 18 to 45 years old; 2. Weight= 50 kg, BMI 19to 24; 3. Valuntery and be able to sign informed consent; 4. The volunteer is able to communicate well with the investigator and be able to complete the study in accordance with the study protocol.;Inclusion criteria: 1. Male and Female aged 18 to 45 years old; 2. Weight= 50 kg, BMI 19to 24; 3. Valuntery and be able to sign informed consent; 4. The volunteer is able to communicate well with the investigator and be able to complete the study in accordance with the study protocol.
Exclusion criteria
Exclusion criteria: 1) any other disease or are currently suffering from previous circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, clinical psychiatry and abnormal metabolism of any serious diseases or can interfere with test results; 2) have allergies to drugs, food or other substances; 3) surgical procedures were performed within 4 weeks of the trial or scheduled for surgery during the study period; 4) anyone who took any medicine (including Chinese herbal medicine) within 14 days before the trial. 5) (interrogation) test in the 30 days before any inhibition or induction of hepatic drug on drug metabolism (such as inducer - barbiturates, phenytoin, C Masi Bing, glucocorticoid, Omeprazole; inhibitor SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles Vera Pammy, sedatives, and fluoroquinolones, antihistamines); 6) taking any clinical trial drug or participating in any clinical trial within 3 months prior to the trial;Nearly a year as a participant participated in 3 or more times clinical trials of drugs; 7) donors within 3 months before the test; 8) volunteer who cannot take 1 or more contraceptives during the test period; 9) women who are pregnant or lactating, 10)the diet has special requirements, can not comply with the unified diet; 11)drink excessive amounts of tea, coffee and / or caffeinated beverages (8 cups or more, 1 =250 mL) per day; 12)smokers or more than 5 smokers per day for the first 3 months of the test; 13)alcoholics or regular drinkers during the first 6 months of the trial, i.e., drinking more than 14 units of alcohol per week (1 units =360, mL beers or 45 mL alcohol, 40% spirits or 150 mL wines); 14) drug abusers or test 3 months before the use of soft drugs (such as marijuana) or test 1 years before taking hard drugs (such as cocaine, phencyclidine etc.); 15) abnormal vital signs (140 mmHg systolic blood pressure, diastolic blood pressure 90 or mmHg 100 BPM; heart rate) or physical examination, electrocardiogram, drug abuse, alcohol screening test, laboratory abnormalities have clinical significance (according to the clinician's judgment as the standard) 16) Tests for HIV, hepatitis B surface antigen, hepatitis C or syphilis serum reactin showed positive; 17) The researcher himself and his family members; 18) subjects may not be able to complete the study for other reasons or the researchers believe that they should not be included.;Exclusion criteria: 1) any other disease or are currently suffering from previous circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, clinical psychiatry and abnormal metabolism of any serious diseases or can interfere with test results; 2) have allergies to drugs, food or other substances; 3) surgical procedures were performed within 4 weeks of the trial or scheduled for surgery during the study period; 4) anyone who took any medicine (including Chinese herbal medicine) within 14 days before the trial. 5) (interrogation) test in the 30 days before any inhibition or induction of hepatic drug on drug metabolism (such as inducer - barbiturates, phenytoin, C Masi Bing, glucocorticoid, Omeprazole; inhibitor SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles Vera Pammy, sedatives, and fluoroquinolones, antihistamines); 6) taking any clinical trial drug or participating in any clinical trial within 3 months prior to the trial;Nearly a year as a participant participated in 3 or more times clinical trials of drugs; 7) donors within 3 months before the test; 8) volunteer who cannot take 1 or more contraceptives during the test period; 9) women who are pregnant or lactating, 10)the diet has special requirements, can not comply with the unified diet; 11)drink excessive amounts of tea, coffee and / or caffeinated beverages (8 cups or more, 1 =250 mL) per day; 12)smokers or more than 5 smokers per day for the first 3 months of the test; 13)alcoholics or regular drinkers during the first 6 months of the trial, i.e., drinking more than 14 units of alcohol per week (1 units =360, mL beers or 45 mL alcohol, 40% spirits or 150 mL wines); 14) drug abusers or test 3 months before the use of soft drugs (such as marijuana) or test 1 years before taking hard drugs (such as cocaine, phencyclidine etc.); 15) abnormal vital signs (140 mmHg systolic blood pressure, diastolic blood pressure 90 or mmHg 100 BPM; heart rate) or physical examination, electrocardiogram, drug abuse, alcohol screening test, laboratory abnormalities have clinical significance (according to the clinician's judgment as the standard) 16) Tests for HIV, hepatitis B surface antigen, hepatitis C or syphilis serum reactin showed positive; 17) The researcher himself and his family members; 18) subjects may not be able to complete the study for other reasons or the researchers believe that they should not be included.;Exclusion criteria: 1) any other disease or are currently suffering from previous circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, clinical psychiatry and abnormal metabolism of any serious diseases or can interfere with test results; 2) have allergies to drugs, food or other substances; 3) surgical procedures were performed within 4 weeks of the trial or scheduled for surgery during the study period; 4) anyone who took any medicine (including Chinese herbal medicine) within 14 days before the trial. 5) (interrogation) test in the 30 days before any inhibition or induction of hepatic drug on drug metabolism (such as inducer - barbiturates, phenytoin, C Masi Bing, glucocorticoid, Omeprazole; inhibitor SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles Vera Pammy, sedatives, and fluoroquinolones, antihistamines); 6) taking any clinical trial drug or participating in any clinical trial within 3 months prior to the trial;Nearly a year as a participant participated in 3 or more times clinical trials of drugs; 7) donors within 3 months before the test; 8) volunteer who cannot take 1 or more contraceptives during the test period; 9) women who are pregnant or lactating, 10)the diet has special requirements, can not comply with the unified diet; 11)drink excessive amounts of tea, coffee and / or caffeinated beverages (8 cups or more, 1 =250 mL) per day; 12)smokers or more than 5 smokers per day for the first 3 months of the test; 13)alcoholics or regular drinkers during the first 6 months of the trial, i.e., drinking more than 14 units of alcohol per week (1 units =360, mL beers or 45 mL alcohol, 40% spirits or 150 mL wines); 14) drug abusers or test 3 months before the use of soft drugs (such as marijuana) or test 1 years before taking hard drugs (such as cocaine, phencyclidine etc.); 15) abnormal vital signs (140 mmHg systolic blood pressure, diastolic blood pressure 90 or mmHg 100 BPM; heart rate) or physical examination, electrocardiogram, drug abuse, alcohol screening test, laboratory abnormalities have clinical significance (according to the clinician's judgment as the standard) 16) Tests for HIV, hepatitis B surface antigen, hepatitis C or syphilis serum reactin showed positive; 17) The researcher himself and his family members; 18) subjects may not be able to complete the study for other reasons or the researchers believe that they should not be included.;Exclusion criteria: 1) any other disease or are currently suffering from previous circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, clinical psychiatry and abnormal metabolism of any serious diseases or can interfere with test results; 2) have allergies to drugs, food or other substances; 3) surgical procedures were performed within 4 weeks of the trial or scheduled for surgery during the study period; 4) anyone who took any medicine (including Chinese herbal medicine) within 14 days before the trial. 5) (interrogation) test in the 30 days before any inhibition or induction of hepatic drug on drug metabolism (such as inducer - barbiturates, phenytoin, C Masi Bing, glucocorticoid, Omeprazole; inhibitor SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles Vera Pammy, sedatives, and fluoroquinolones, antihistamines); 6) taking any clinical trial drug or participating in any clinical trial within 3 months prior to the trial;Nearly a year as a participant participated in 3 or more times clinical trials of drugs; 7) donors within 3 months before the test; 8) volunteer who cannot take 1 or more contraceptives during the test period; 9) women who are pregnant or lactating, 10)the diet has special requirements, can not comply with the unified diet; 11)drink excessive amounts of tea, coffee and / or caffeinated beverages (8 cups or more, 1 =250 mL) per day; 12)smokers or more than 5 smokers per day for the first 3 months of the test; 13)alcoholics or regular drinkers during the first 6 months of the trial, i.e., drinking more than 14 units of alcohol per week (1 units =360, mL beers or 45 mL alcohol, 40% spirits or 150 mL wines); 14) drug abusers or test 3 months before the use of soft drugs (such as marijuana) or test 1 years before taking hard drugs (such as cocaine, phencyclidine etc.); 15) abnormal vital signs (140 mmHg systolic blood pressure, diastolic blood pressure 90 or mmHg 100 BPM; heart rate) or physical examination, electrocardiogram, drug abuse, alcohol screening test, laboratory abnormalities have clinical significance (according to the clinician's judgment as the standard) 16) Tests for HIV, hepatitis B surface antigen, hepatitis C or syphilis serum reactin showed positive; 17) The researcher himself and his family members; 18) subjects may not be able to complete the study for other reasons or the researchers believe that they should not be included.;Exclusion criteria: 1) any other disease or are currently suffering from previous circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, clinical psychiatry and abnormal metabolism of any serious diseases or can interfere with test results; 2) have allergies to drugs, food or other substances; 3) surgical procedures were performed within 4 weeks of the trial or scheduled for surgery during the study period; 4) anyone who took any medicine (including Chinese herbal medicine) within 14 days before the trial. 5) (interrogation) test in the 30 days before any inhibition or induction of hepatic drug on drug metabolism (such as inducer - barbiturates, phenytoin, C Masi Bing, glucocorticoid, Omeprazole; inhibitor SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles Vera Pammy, sedatives, and fluoroquinolones, antihistamines); 6) taking any clinical trial drug or participating in any clinical trial within 3 months prior to the trial;Nearly a year as a participant participated in 3 or more times clinical trials of drugs; 7) donors within 3 months before the test; 8) volunteer who cannot take 1 or more contraceptives during the test period; 9) women who are pregnant or lactating, 10)the diet has special requirements, can not comply with the unified diet; 11)drink excessive amounts of tea, coffee and / or caffeinated beverages (8 cups or more, 1 =250 mL) per day; 12)smokers or more than 5 smokers per day for the first 3 months of the test; 13)alcoholics or regular drinkers during the first 6 months of the trial, i.e., drinking more than 14 units of alcohol per week (1 units =360, mL beers or 45 mL alcohol, 40% spirits or 150 mL wines); 14) drug abusers or test 3 months before the use of soft drugs (such as marijuana) or test 1 years before taking hard drugs (such as cocaine, phencyclidine etc.); 15) abnormal vital signs (140 mmHg systolic blood pressure, diastolic blood pressure 90 or mmHg 100 BPM; heart rate) or physical examination, electrocardiogram, drug abuse, alcohol screening test, laboratory abnormalities have clinical significance (according to the clinician's judgment as the standard) 16) Tests for HIV, hepatitis B surface antigen, hepatitis C or syphilis serum reactin showed positive; 17) The researcher himself and his family members; 18) subjects may not be able to complete the study for other reasons or the researchers believe that they should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| drug plasma 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