postoperative
Conditions
Interventions
experimental group:inject HYR-PB21
positive-control group:inject positive control drug
placebo group:inject placebo
Sponsors
The First Affiliated Hospital of Yunnan University of Chinese Medicine (Yunnan Hospital of Traditional Chinese Medicine)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: All the following conditions must be met: (1) Before the trial, I have understood the nature, significance, potential benefits, inconvenience and potential risks and discomfort of the trial in detail, and I have volunteered to participate in the clinical trial. I have been able to communicate well with researchers, comply with the requirements of the whole study, and have signed written informed consent. (2) Healthy volunteers, male aged 18~50 years old, female non-pregnant and non-lactating;Body mass index (BMI) was within the range of [19.0 ~ 25.0]kg/m2.Male body weight is greater than 50.0kg, female body weight is greater than 45.0 kg. (3) Normal or abnormal physical examination, vital signs and laboratory examination have no clinical significance. (4) During the study period and within 60 days after the end of the study, the volunteers had no fertility or sperm/egg donation programs and were willing to take effective physical contraceptive measures.
Exclusion criteria
Exclusion criteria: If you meet any of the following criteria, you will not be included: (1) Allergic history of amide anesthetics;Persons with a known history of allergy to pharmaceutical ingredients and excipients;Self-reported susceptibility to allergies. (2) Any history of disease that may affect the safety of the trial and the in vivo process assessment of the drug;Currently suffering from any unstable or recurrent disease or disease that affects in vivo processes of the drug. (3) Take any medicine, including over-the-counter drugs and Herbal medicines, within 14 days before the trial. (4) Those who have participated in clinical trials of drugs or devices within 3 months before the trial and have received treatment with drugs or devices. (5) Those who had lost blood or donated blood of 200 mL or more in the 90 days before the test (except for female menstrual blood loss) and intended to donate blood or donate blood components during the study period or within 1 month after the study. (6) A history of drug dependence or positive substance abuse screening in the past 2 years;Smokers who smoked more than 10 cigarettes a day or the same amount of tobacco during the 3 months (90 days) before the trial, or who smoked lightly and were unable to quit during the trial period;Drinking more than 28 units of alcohol [1 unit =285ml beer or 25ml spirits (>= 50 degrees) or 150ml wine] per week for 3 months (90 days) prior to the trial, or light alcohol with no abstinence during the trial period;Excessive intake of tea, coffee, or caffeinated beverages (an average of more than 8 cups per day, 200 mL per cup) per day for 1 month (30 days) prior to the trial. (7) A history of fainting needles or blood;Unable to tolerate venipuncture blood collection. (8) Physical examination, vital signs examination, laboratory examination, electrocardiogram examination, etc., with abnormal and clinically significant indicators. For example, systolic/diastolic blood pressure is greater than 139/89mmHg, ALT is 1.5 times higher than the upper limit of normal value, atrioventricular block with clinical significance, arrhythmia, etc. (9) the QTcF interval was significantly prolonged (for example, the screening period was first checked for > 450ms in QTcF interval, and the test value was > 450ms for three consecutive times, or the mean > 450ms for three times); Presence of other risk factors for TdP (such as heart failure, hypokalemia, hypomagnesemia, bradycardia, and hereditary long QT syndrome); Drugs that cause the QT/QTc interval to lengthen should also be used. (10) Screening for positive blood or urine pregnancy test, or women who are pregnant or lactating, or who are likely to become pregnant during the test. (11) Lack of history of glucose-6-phosphate dehydrogenase (G6PD). (12) Insufficient understanding, communication and cooperation of the volunteers can not guarantee that they will cooperate with the researchers according to the plan. (13) Other factors considered unsuitable by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plesma concentration;Analgesic effect; | — |
Countries
China
Contacts
Public ContactJianchang He, Ping Zhang
The First Affiliated Hospital of Yunnan University of Chinese Medicine
Outcome results
None listed