agitation
Conditions
Interventions
test preparation-reference preparation:First cycle test preparation T, second cycle reference preparation R
reference preparation-test preparation:First cycle reference preparation Rest preparation T, second cycle test preparation T
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: To be selected, volunteers must meet all of the following criteria. 1) Chinese volunteers aged 18 ~ 45 years (including the threshold), both sexes. 2) Male volunteers weighing =50.0 kg and female volunteers weighing =45.0 kg with a body mass index (BMI) between 19 ~26 kg/m2, including the threshold. 3) Volunteers voluntarily signed a written informed consent form.
Exclusion criteria
Exclusion criteria: Volunteers who meet one or more of the following criteria will be excluded. 1) Those with any previous or current clinically serious diseases of the circulatory, endocrine, neurological, digestive, respiratory, hematological, immunological, psychiatric and metabolic abnormalities or any other diseases that can interfere with the test results, such as those with a previous history of oncology, previous history of cardiovascular disease (e.g. hypertension, bradycardia, tachycardia, arrhythmia (e.g., hypertension, bradycardia, tachycardia, arrhythmia, prolonged QT interval, myocardial infarction, heart failure, etc.). 2) those who have experienced nausea, dizziness, headache, drowsiness, etc. within 7 days prior to the first dose and who are considered by the investigator to be unfit to participate in the trial. 3) those who have undergone surgical procedures within 4 weeks prior to the trial or are scheduled to undergo surgical procedures during the study 4) those who have a history of allergy to drugs, food or other substances; those who are allergic to any of the components of the product and excipients, or have a history of allergic disease (e.g., atopic dermatitis, angioneurotic edema, orofacial edema, urticaria, etc.) and who, in the opinion of the investigator, are still clinically significant 5) Those who have used any drug within 30 days prior to the trial that has a pharmacodynamic effect in prolonging the QT interval, or that is contraindicated in the prescribing information for use in patients with prolonged QTc interval, or that has a black box warning caution for use in patients with prolonged QTc interval 6) those who have used any medication (including vitamins and herbal medicines) within 14 days prior to the trial 7) those who have taken any clinical trial drug or participated in a clinical trial of any drug within 3 months prior to the trial 8) Donated blood or lost more than 200 mL of blood within 3 months prior to the trial, or plan to donate blood or blood components during the study or within 3 months after the study. 8) Those who have donated blood or blood components within 3 months prior to the trial, or those who plan to donate blood or blood components during the study or within 3 months after the study. 9) Volunteers (or their partners) who are planning to become pregnant during the trial until 3 months after the end of the trial, who are planning to donate sperm and eggs, or who are unable to use one or more non-pharmaceutical contraceptive measures (e.g., total abstinence, IUD, partner ligation, etc.) during the trial 10) Pregnant or lactating females, or female volunteers with positive pregnancy test results 11) Those with special dietary requirements who cannot comply with a uniform diet 12) smokers or smokers who smoked more than 5 cigarettes per day in the 3 months before the trial, or who could not stop using any tobacco products during the trial or who cannot stop using any tobacco products during the trial. 13) Alcoholics or regular drinkers in the 6 months prior to the trial, i.e., those who consume more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of alcohol) or 45 mL of 40% alcoholic spirits or 150 mL of wine) per week, or who cannot stop using any product containing alcohol during the trial. alcoholic products during the test. 14) Persons who consume excessive amounts of tea, coffee, and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day 15)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration;Physical examination;vital signs;Adverse reactions;Serious Adverse Events;Twelve-lead electrocardiogram; | — |
Secondary
| Measure | Time frame |
|---|---|
| laboratory teat; | — |
Countries
China
Contacts
Public ContactGuoping Yang
Center for Clinical Pharmacology, the Third Xiangya Hospital of Central South University
Outcome results
None listed