Cardiovascular and cerebrovascular thromboembolic diseases
Conditions
Interventions
A:100 mg p.o test product Sanchi Tongshu Capsule (enteric-coated pellets),washout 14 days, 100 mg p.o reference product Sanchi Tongshu Capsule.
B:100 mg p.o reference product Sanchi Tongshu Capsule, washout 14 days, 100 mg p.o test product Sanchi Tongshu Capsule (enteric-coated pellets).
Sponsors
West China Second Univercity Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18~40 year-old healthy male volunteers, this trail requires the same batch subjects age difference should not exceed 10 years old; 2. Body Mass Index(BMI):Having a BMI between 19 and 24 (inclusive), calculated as weight in kg/(height in m2), and weight at least 50KgBMI of subjects in each group should show no significant difference; 3. Health status:heart, liver, kidney, blood and other tests indicators are in the normal range; 4. habits: no smoking or alcohol habits, no history of drug abuse and agreed to ban drinking caffeinated beverages during the trial; 5. meet the above requirements, and be fully aware of the methods, content, test preparation and reference preparation of this trail, voluntarily signed informed consent.
Exclusion criteria
Exclusion criteria: 1. showed any significant clinical disease through direct questions and a comprehensive physical examination and laboratory tests before trails; 2. History of any severe disease or surgical conditions in the previous 30 days (except researchers think no clinical significance); Or have stomach liver and kidney disease patients; Or have other factors affecting absorption distribution, metabolism and excretion, etc 3 serological examination, laboratory tests or clinical signs and symptoms consistent with active viral hepatitis, whether acute or chronic; 4. Allergic constitution, such as the history of two or more drugs and food allergies; or have allergies to the drug ingredients of this trail; 5. taking any prescription or non-prescription drugs two weeks before taking the first dose of study drug; 6. accept any experimental drugs four months before the date of the first agent of this trail. 7. There is evidence for drug abusers; 8. drinking more than 28 units of alcohol per week (1 unit = 285ml beer or 25ml spirits or a glass of wine); 9. smoke over 10 cigarette or an equivalent amount of tobacco daily; 10. drinking tea, coffee, and / or those containing caffeine during the trail; 11. within two week before the first time taking drug in this trail ,have ever smoked or taken products containing nicotine(including, but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine tablets, nicotine gum), or have drank within one week before the first time taking drug in this trail; 12. have donated blood in the month prior to the study, or intend to donate blood or blood components during the trail or within one month after the end of study; 13. According to investigator's judgment, has a lower possibility of enrollment (such as the infirm, etc.); 14. researchers believe subjects may not be completed this trail for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC(0-8);AUC(0-t); | — |
Countries
China
Contacts
Public ContactWang Ling
Pharmaceutical Factory Of Chengdu Huasun Group Inc.,Ltd
Outcome results
None listed