None listed
Conditions
Interventions
A?B and C group:Cross-administration
Sponsors
Phase I clinical study room of The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18-40 years old men and women; 2) Weight: male = 50.0 kg, female = 45.0kg, BMI between 19 ~ 26 kg/m2, including the boundary value; 3) Subjects must have informed willingness of this study before the trial and willingness must voluntarily signed a written informed consent; 4) To be able to well communicate with researcher.;Inclusion criteria: 1) Aged 18-40 years old men and women; 2) Weight: male = 50.0 kg, female = 45.0kg, BMI between 19 ~ 26 kg/m2, including the boundary value; 3) Subjects must have informed willingness of this study before the trial and willingness must voluntarily signed a written informed consent; 4) To be able to well communicate with researcher.;Inclusion criteria: 1) Aged 18-40 years old men and women; 2) Weight: male = 50.0 kg, female = 45.0kg, BMI between 19 ~ 26 kg/m2, including the boundary value; 3) Subjects must have informed willingness of this study before the trial and willingness must voluntarily signed a written informed consent; 4) To be able to well communicate with researcher.;Inclusion criteria: 1) Aged 18-40 years old men and women; 2) Weight: male = 50.0 kg, female = 45.0kg, BMI between 19 ~ 26 kg/m2, including the boundary value; 3) Subjects must have informed willingness of this study before the trial and willingness must voluntarily signed a written informed consent; 4) To be able to well communicate with researcher.;Inclusion criteria: 1) Aged 18-40 years old men and women; 2) Weight: male = 50.0 kg, female = 45.0kg, BMI between 19 ~ 26 kg/m2, including the boundary value; 3) Subjects must have informed willingness of this study before the trial and willingness must voluntarily signed a written informed consent; 4) To be able to well communicate with researcher.
Exclusion criteria
Exclusion criteria: 1) any other serious illness that is present or currently suffering from circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormality, or any other disease that can interfere with the test results; 2) Drugs (penicillins or cephalosporins), food or a history of allergy to test drugs or similar drugs; 3) Surgery was performed within 4 weeks prior to the trial, or surgery was planned during the study period; 4) Those who have taken any medicine within 14 days before the trial (including Chinese herbal medicine); (Eg, inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole, inhibitors - SSRI antidepressants) that have been used to inhibit or induce liver metabolism within 30 days of the trial 6, 3 months prior to the test, any of the patients who participated in any of the three drugs were treated with cimetidine, diclazurine, macrolide, nitroimidazole, sedative hypnotics, verapamil, fluoroquinolones, antihistamines) Drug clinical trials and the use of any test drug; 7) within 4 months before the test to participate in blood donation and blood donation> 400mL, or received blood transfusion; 8) One or more nonpharmacological contraceptives can not be used during the trial period or are planned to be born within six months; 9) have special requirements for diet, can not comply with the unified diet; 10) Drink plenty of tea, coffee and / or caffeinated beverages (8 cups, 1 cup = 250 mL) per day; 11) smokers or 3 months before the test more than 5 daily smokers; 12) Alcoholics or regular drinking within 6 months before the trial, that is, more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine); 13) Drug abusers or soft drugs (eg, cannabis) used within 3 months prior to testing or taking hard drugs (eg cocaine, phenylcyclohexapyridine, etc.) within 1 year before the trial; 14) 2 days before randomization with caffeine, alcoholic beverages, edible grapefruit and other citrus fruits or juices, strenuous exercise, or other effects of drug absorption, distribution, metabolism, excretion and other factors; 15) is not suitable for nasal spray or is not willing to accept nasal administration; 16) Pregnant or lactating women; 17) Abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 bpm) or physical examination, nasal endoscopy, electrocardiogram, Heart color Doppler ultrasound, thyroid function, blood oxygen saturation, laboratory tests and other abnormal clinical significance (to determine the clinician); 18) Subjects may not be able to complete this study or researcher who should not be included for other reasons.;Exclusion criteria: 1) any other serious illness that is present or currently suffering from circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormality, or any other disease that can interfere with the test results; 2) Drugs (penicillins or cephalosporins), food or a history of allergy to test drugs or similar drugs; 3) Surgery was performed within 4 weeks prior to the trial, or surgery was planned during the study period; 4) Those who have taken any medicine within 14 days before the trial (including Chinese herbal medicine); (Eg, inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole, inhibitors - SSRI antidepressants) that have been used to inhibit or induce liver metabolism within 30 days of the trial 6, 3 months prior to the test, any of the patients who participated in any of the three drugs were treated with cimetidine, diclazurine, macrolide, nitroimidazole, sedative hypnotics, verapamil, fluoroquinolones, antihistamines) Drug clinical trials and the use of any test drug; 7) within 4 months before the test to participate in blood donation and blood donation> 400mL, or received blood transfusion; 8) One or more nonpharmacological contraceptives can not be used during the trial period or are planned to be born within six months; 9) have special requirements for diet, can not comply with the unified diet; 10) Drink plenty of tea, coffee and / or caffeinated beverages (8 cups, 1 cup = 250 mL) per day; 11) smokers or 3 months before the test more than 5 daily smokers; 12) Alcoholics or regular drinking within 6 months before the trial, that is, more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine); 13) Drug abusers or soft drugs (eg, cannabis) used within 3 months prior to testing or taking hard drugs (eg cocaine, phenylcyclohexapyridine, etc.) within 1 year before the trial; 14) 2 days before randomization with caffeine, alcoholic beverages, edible grapefruit and other citrus fruits or juices, strenuous exercise, or other effects of drug absorption, distribution, metabolism, excretion and other factors; 15) is not suitable for nasal spray or is not willing to accept nasal administration; 16) Pregnant or lactating women; 17) Abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 bpm) or physical examination, nasal endoscopy, electrocardiogram, Heart color Doppler ultrasound, thyroid function, blood oxygen saturation, laboratory tests and other abnormal clinical significance (to determine the clinician); 18) Subjects may not be able to complete this study or researcher who should not be included for other reasons.;Exclusion criteria: 1) any other serious illness that is present or currently suffering from circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormality, or any other disease that can interfere with the test results; 2) Drugs (penicillins or cephalosporins), food or a history of allergy to test drugs or similar drugs; 3) Surgery was performed within 4 weeks prior to the trial, or surgery was planned during the study period; 4) Those who have taken any medicine within 14 days before the trial (including Chinese herbal medicine); (Eg, inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole, inhibitors - SSRI antidepressants) that have been used to inhibit or induce liver metabolism within 30 days of the trial 6, 3 months prior to the test, any of the patients who participated in any of the three drugs were treated with cimetidine, diclazurine, macrolide, nitroimidazole, sedative hypnotics, verapamil, fluoroquinolones, antihistamines) Drug clinical trials and the use of any test drug; 7) within 4 months before the test to participate in blood donation and blood donation> 400mL, or received blood transfusion; 8) One or more nonpharmacological contraceptives can not be used during the trial period or are planned to be born within six months; 9) have special requirements for diet, can not comply with the unified diet; 10) Drink plenty of tea, coffee and / or caffeinated beverages (8 cups, 1 cup = 250 mL) per day; 11) smokers or 3 months before the test more than 5 daily smokers; 12) Alcoholics or regular drinking within 6 months before the trial, that is, more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine); 13) Drug abusers or soft drugs (eg, cannabis) used within 3 months prior to testing or taking hard drugs (eg cocaine, phenylcyclohexapyridine, etc.) within 1 year before the trial; 14) 2 days before randomization with caffeine, alcoholic beverages, edible grapefruit and other citrus fruits or juices, strenuous exercise, or other effects of drug absorption, distribution, metabolism, excretion and other factors; 15) is not suitable for nasal spray or is not willing to accept nasal administration; 16) Pregnant or lactating women; 17) Abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 bpm) or physical examination, nasal endoscopy, electrocardiogram, Heart color Doppler ultrasound, thyroid function, blood oxygen saturation, laboratory tests and other abnormal clinical significance (to determine the clinician); 18) Subjects may not be able to complete this study or researcher who should not be included for other reasons.;Exclusion criteria: 1) any other serious illness that is present or currently suffering from circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormality, or any other disease that can interfere with the test results; 2) Drugs (penicillins or cephalosporins), food or a history of allergy to test drugs or similar drugs; 3) Surgery was performed within 4 weeks prior to the trial, or surgery was planned during the study period; 4) Those who have taken any medicine within 14 days before the trial (including Chinese herbal medicine); (Eg, inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole, inhibitors - SSRI antidepressants) that have been used to inhibit or induce liver metabolism within 30 days of the trial 6, 3 months prior to the test, any of the patients who participated in any of the three drugs were treated with cimetidine, diclazurine, macrolide, nitroimidazole, sedative hypnotics, verapamil, fluoroquinolones, antihistamines) Drug clinical trials and the use of any test drug; 7) within 4 months before the test to participate in blood donation and blood donation> 400mL, or received blood transfusion; 8) One or more nonpharmacological contraceptives can not be used during the trial period or are planned to be born within six months; 9) have special requirements for diet, can not comply with the unified diet; 10) Drink plenty of tea, coffee and / or caffeinated beverages (8 cups, 1 cup = 250 mL) per day; 11) smokers or 3 months before the test more than 5 daily smokers; 12) Alcoholics or regular drinking within 6 months before the trial, that is, more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine); 13) Drug abusers or soft drugs (eg, cannabis) used within 3 months prior to testing or taking hard drugs (eg cocaine, phenylcyclohexapyridine, etc.) within 1 year before the trial; 14) 2 days before randomization with caffeine, alcoholic beverages, edible grapefruit and other citrus fruits or juices, strenuous exercise, or other effects of drug absorption, distribution, metabolism, excretion and other factors; 15) is not suitable for nasal spray or is not willing to accept nasal administration; 16) Pregnant or lactating women; 17) Abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 bpm) or physical examination, nasal endoscopy, electrocardiogram, Heart color Doppler ultrasound, thyroid function, blood oxygen saturation, laboratory tests and other abnormal clinical significance (to determine the clinician); 18) Subjects may not be able to complete this study or researcher who should not be included for other reasons.;Exclusion criteria: 1) any other serious illness that is present or currently suffering from circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormality, or any other disease that can interfere with the test results; 2) Drugs (penicillins or cephalosporins), food or a history of allergy to test drugs or similar drugs; 3) Surgery was performed within 4 weeks prior to the trial, or surgery was planned during the study period; 4) Those who have taken any medicine within 14 days before the trial (including Chinese herbal medicine); (Eg, inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole, inhibitors - SSRI antidepressants) that have been used to inhibit or induce liver metabolism within 30 days of the trial 6, 3 months prior to the test, any of the patients who participated in any of the three drugs were treated with cimetidine, diclazurine, macrolide, nitroimidazole, sedative hypnotics, verapamil, fluoroquinolones, antihistamines) Drug clinical trials and the use of any test drug; 7) within 4 months before the test to participate in blood donation and blood donation> 400mL, or received blood transfusion; 8) One or more nonpharmacological contraceptives can not be used during the trial period or are planned to be born within six months; 9) have special requirements for diet, can not comply with the unified diet; 10) Drink plenty of tea, coffee and / or caffeinated beverages (8 cups, 1 cup = 250 mL) per day; 11) smokers or 3 months before the test more than 5 daily smokers; 12) Alcoholics or regular drinking within 6 months before the trial, that is, more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine); 13) Drug abusers or soft drugs (eg, cannabis) used within 3 months prior to testing or taking hard drugs (eg cocaine, phenylcyclohexapyridine, etc.) within 1 year before the trial; 14) 2 days before randomization with caffeine, alcoholic beverages, edible grapefruit and other citrus fruits or juices, strenuous exercise, or other effects of drug absorption, distribution, metabolism, excretion and other factors; 15) is not suitable for nasal spray or is not willing to accept nasal administration; 16) Pregnant or lactating women; 17) Abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 bpm) or physical examination, nasal endoscopy, electrocardiogram, Heart color Doppler ultrasound, thyroid function, blood oxygen saturation, laboratory tests and other abnormal clinical significance (to determine the clinician); 18) Subjects may not be able to complete this study or researcher who should not be included for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum drug 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