Long-term congestive heart failure caused by chest tightness, asthma, cough, edema, limbs, cold, fatigue
Conditions
Interventions
test group:Multiple administration
Sponsors
Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) pre-test 2 cases of healthy male volunteers, the formal test of 12 healthy volunteers (men and women half). Age 18-35 years old, the same batch of subjects should not be younger than 10 years of age; (2) Male subjects weighing no less than 50Kg, female subjects weighing no less than 45Kg, body mass index in 19-24 (including the critical value); (3) smoke detection, alcohol testing and drug abuse test qualified, general physical examination and laboratory tests, chest X-ray, ECG and other physical and chemical tests are normal. (4) no history of major diseases, no smoking and alcoholism, women of childbearing age pregnancy test negative and not in lactation; (5) Pre-trial subjects have a detailed understanding of the nature, significance, possible benefits, and possible inconvenience and potential hazards of the trial, understanding the research process, and voluntarily signing written informed consent forms and completing the required checks.
Exclusion criteria
Exclusion criteria: (1) heart and kidney and other important organs have primary disease, history of gastrointestinal disease, metabolic disease history, history of neurological diseases; (2) QTcB extension (male> 450ms, female> 470ms); (3) have a history of drug allergy or allergies; (4) have hypokalemia and long QT family history of TdP risk factors such as family members; (5) patients with mental or physical disabilities; (6) physical examination, biochemistry, hematuria will be conventional and ECG, chest X-ray, ultrasound abnormalities, and clinical significance; (7) hepatitis B test, anti-HCV, HIV antibody test was positive; (8) within 3 months using known to have damage to an organism drugs, nearly 2 weeks had taken any drugs, 4 weeks participated in other clinical trials; (9) have bleeding tendency; (10) menstrual period, gestational age, lactating women and women of childbearing age taking contraceptives; (11) Abnormal vital signs (systolic blood pressure 140mmHg, diastolic blood pressure 90mmHg; heart rate 100bpm); (12) 3 months before the test more than 1 daily smoking or use a considerable amount of nicotine products, during the trial can not quit smoking, smoke test is positive; (13) Drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of alcohol), or alcohol test positive; (14) Drink plenty of tea, coffee and / or caffeinated beverages (8 cups or more, 1 cup = 250 mL) per day; (15) blood transfusion and blood donation history (blood volume greater than 200mL) in the last 3 months; (16) previous history of drug abuse, drug abuse test (morphine, methamphetamine, ketamine, dimethyl dioxy amphetamine, tetrahydrocannabinol, cocaine) positive; (17) According to the judge's judgment, not into the group (such as frail, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood drug concentration;QT/QTc interval;Cmax;Tmax; | — |
Countries
China
Contacts
Public ContactHuang Yuhong
Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed