Tachyarrhythmias
Conditions
Interventions
Experimental group:On Day D1, trial participants were administered intravenously at a rate of 0.125 mg/kg/min for 1 minute while fasting, followed by adjustment of the rate to 0.04 mg/kg/min for conti
Sponsors
Clinical Trial Center of Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Male or female trial participants aged 18 to 45 years (inclusive); 2.Male weight >=50.0kg, female weight >=45.0kg, body mass index (BMI) between 19 and 26kg/m^2, inclusive of boundary values; 3.Trial participants voluntarily sign the informed consent form and fully understand the content, process, and possible adverse reactions of the trial; 4.The study participants can communicate well with the investigators, and understand and comply with all requirements of this research.
Exclusion criteria
Exclusion criteria: 1.The patient has clinical significance due to abnormal medical history inquiry, physical examination, vital signs examination (blood pressure, body temperature, pulse), blood routine, blood biochemistry, urine routine, 12- lead electrocardiogram, blood coagulation function, hepatitis B surface antigen (HBs-Ag), human immunodeficiency virus antigen antibody, hepatitis C antibody and Treponema pallidum antibody; 2. heart rate < 60 beats/min, diastolic blood pressure < <60mmHg or systolic blood pressure < <90mmHg in the screening period; 3.(screening period/check-in) Those with previous history of hypotension; 4. (screening period/check-in) Those with previous history of bronchospasm; 5. (Screening period/check-in) Persons with previous history of circulatory diseases: such as coronary heart disease, unstable angina pectoris, acute myocardial infarction, congestive heart failure, cardiac insufficiency caused by pulmonary hypertension, cardiogenic shock, bradycardia such as atrioventricular block with degree II or above, sick sinus syndrome, or peripheral circulatory disorders (such as gangrene, Raynaud's syndrome, intermittent claudication, etc.); 6. (screening period/check-in) Persons with previous endocrine system diseases, such as diabetic ketosis, hyperthyroidism and metabolic acidosis; 7. (screening period/check-in) Those who have a serious history of mental illness or chronic disease of heart, liver, kidney, endocrine, digestive tract, blood system, respiratory system, immune system and nervous system or have the above-mentioned system diseases; 8. (screening period/check-in consultation) Those who have used any drugs (including prescription drugs, over-the-counter drugs, vitamin supplements or Chinese herbal medicines) and health products within two weeks before check-in; 9. (screening period/check-in consultation) Those who were vaccinated within 2 weeks before check-in or planned to be vaccinated during the trial period; 10. (consultation during the screening period) Those who are known to be allergic or contraindicated to ß1 receptor blockers such as Landirol; 11. (screening period/check-in) Those who have a history of drug abuse or used drugs within one year; 12. (screening period/check-in) Those who smoke more than 5 cigarettes a day on average in the three months before the first drug administration in the trial, or who cannot stop using any tobacco products (nicotine-containing products) during the trial; 13. (screening period/check-in) Those who regularly drank alcohol within 6 months before the first administration in the trial, that is, those who drank more than 14 units of alcohol per week (1 unit is equal to 17.5mL or 14g pure alcohol, and the alcohol content of different varieties is marked by volume ratio, and 1 alcohol unit is equal to 35mL of 50-degree white wine or 350mL of 5-degree beer), or those who are unwilling to stop drinking or eat any alcoholic products during the whole trial; 14. (screening period/check-in consultation+online screening) Those who have participated in any drug clinical trials and used the experimental drugs within 3 months before check-in; 15. (screening period/check-in consultation) Those who have received any surgery or planned surgery during the trial within 6 months before check-in; 16. (screening consultation) those who can't accept venipuncture and have a history of needle fainting and blood fainting; 17. (screening period/check-in consultation) Those who have donated blood or lost 4
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic ; | — |
Secondary
| Measure | Time frame |
|---|---|
| 12-lead electrocardiogram indicators ;Vital signs;Electrocardiographic monitoring; | — |
Countries
China
Contacts
Public ContactYang Guoping
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed