None
Conditions
Interventions
Experimental group:Sailuotong capsule
Sponsors
Hebei Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1.Completely healthy male subjects of Han nationality after medical history and physical examination; 2.Aged 18 to 40 years; 3.The body mass index at the time of screening is within 19-26 kg/m^2 (inclusive), and those who are overweight or underweight should be avoided, and the weight should generally not be less than 50kg; 4.During the screening, the clinical laboratory examination and electrocardiogram were normal or the abnormality judged by the investigator had no clinical significance; 5.Good compliance, able to participate in the trial according to the protocol throughout the trial process, and willing to accept follow-up; 6.Sign the written informed consent before the trial.
Exclusion criteria
Exclusion criteria: 1.Patients with a history of drug abuse; 2.Patients who have participated in clinical trials of other drugs within 3 months; 3.Patients who have used any prescription drugs, non-prescription drugs, Chinese herbal medicines and health products within 2 weeks before administration; 4.Alcoholics, with an average weekly alcohol intake of more than 14 units or unable to comply with alcohol restrictions during the study period (1 unit = 200 mL of 5% alcoholic beer or 25 mL of 40% alcoholic liquor or 12% alcoholic beverages) wine 83 mL); 5.Smokers (including those who have smoked continuously or cumulatively for >=6 months and quit smoking for less than 1 month); drug addicts; those who drink more than 1L/day of tea and coffee; 6.Patients who donated blood or lost more than 200 ml of blood within 3 months; 7.Allergic constitution (allergic to two or more drugs, food, pollen); 8.Patients who have a history of cardiovascular, respiratory, liver, kidney, digestive tract, endocrine, blood or mental and neurological diseases in the past or have the above diseases; 9.The spouse of the subject is planning to become pregnant within the past six months; 10.Patients with bleeding tendency; 11.Subjects who are judged by the investigator and cannot be enrolled for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| General observation index;Laboratory examination index;Adverse event observation;Pharmacokinetic indicators;Evaluation index; | — |
Countries
China
Contacts
Public ContactZhang Ying
Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine
Outcome results
None listed