None listed
Conditions
Interventions
A:First period: new prescription preparation, second period: old prescription preparation
B:First period: old prescription preparation, second period: new prescription preparation
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Understand the nature, significance, potential benefits, inconvenience and potential risks of the test, understand the research procedures and sign the informed consent voluntarily before the test. 2) Subjects can communicate well with researchers and complete the study in accordance with the research regulations. 3) Healthy males and females aged 18 to 45 years; 4) Women weigh more than or equal to 45.0 kg, men weigh more than or equal to 50.0 kg, and subjects'body mass index (BMI) ranges from 19 to 26 kg/m2 (BMI = body weight (kg)/height 2 (m2), including the boundary value; 5) Subjects (including male subjects) promised that they would take effective contraceptive measures voluntarily and without family planning from signing informed consent, during the use of experimental drugs and within six months after withdrawal.
Exclusion criteria
Exclusion criteria: 1) The abnormalities of clinical significance judged by clinicians, including physical examination, vital signs examination, electrocardiogram or clinical laboratory examination, or serious medical history of heart, liver, kidney, digestive tract, nervous system, respiratory system, blood and lymph, endocrine, immune, psychiatric and metabolic abnormalities, to study physicians. Not suitable for participants; 2) There are any diseases that interfere with the absorption, distribution, metabolism or excretion of drugs in the past or at present, which the researchers consider inappropriate to participate in. 3) HIV, HBsAg, hepatitis C or syphilis positive; 4) People with a specific allergic history (asthma, measles, eczema, etc.), or allergic constitution (such as those allergic to two or more medicines, food such as milk and pollen), or those who are known to be allergic to the components or analogues of this drug; 5) Alcoholics or regular drinkers within 6 months before the trial, i.e. those who drank more than 14 units of alcohol per week (1 unit = 360 mL beer or 40% spirits or 150 mL wine with 45 mL alcohol); 6) Female subjects were in breast-feeding or pregnancy positive during screening or clinical trials. 7) Positive drug screeners or those who have a history of drug abuse in the past five years or used drugs three months before taking drugs; 8) Unqualified Cognitive Function Examination; 9) Smokers or those who smoked more than 5 cigarettes a day three months before the trial, or subjects could not quit smoking 48 hours before and during the trial; 10) Blood donation or massive blood loss (>400 mL) within 3 months before the use of the research drug; 11) Three months before the use of the research drug, there was a history of surgery or the use of the research drug or the participation of other drug clinical trials. 12) Any drugs that inhibit or induce liver metabolism (e.g. inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole) and inhibitors-SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-induced drugs) were used within 30 days before taking the study drugs. Sleeping pills, verapamil, fluoroquinolones and antihistamines; 13) Take any prescription drug within 14 days before using the research drug; 14) Take any over-the-counter medicines, Chinese herbal medicines or health products within 7 days before the use of the research medicines; 15) Those who had taken special diet (such as grapefruit and products containing grapefruit ingredients) or had vigorous exercise or other factors affecting drug absorption, distribution, metabolism and excretion within 48 hours before the use of the research drug; 16) Chocolate, any caffeine or xanthine-rich foods (such as animal liver) were ingested 48 hours before the use of the drug. 17) Those who had taken any alcohol-containing products or had positive alcohol screening within 24 hours before the use of the research drug; 18) Difficult airway patients, including the modified Malampati grade III-IV patients, congenital tongue, mandibular dysplasia and other patients; 19) Those who take sedative drugs for a long time; 20) Other researchers determined the unsuitable participants. Tho
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters;MOAA/S;The time of disappearance and recovery of eyelash reflex;BIS; | — |
Countries
China
Contacts
Public ContactHui Yang
West China Hospital, Sichuan University
Outcome results
None listed