Anti-thrombosis
Conditions
Interventions
Treatment group:Oral administration of Sarpogrelate Hydrochloride Tablets, 1tablet / time
Control group:Oral administration of Sarpogrelate Hydrochloride Tablets, 1tablet / time
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: The volunteers must meet the following conditions: 1) Healthy male Chinese volunteers aged from 18 to 40, BW more than 50 kg, and ages should not differ more than 10 years old between the volunteers; 2) BMI = weight (kg) / height 2 (m2),and a body mass index between 19 to 24. The weight of volunteers in same group should be similar; 3) Healthy status: no heart, liver, kidney, digestive system, nervous system, mental disorders and metabolic disorders and other medical history. The physical examination showed blood pressure, heart rate, ECG, respiratory system, liver function, kidney function and blood RT no abnormal; 4) No birth plan during the study and within three months after the study; 5) Signed the ICF before the study, and understood the content, process and adverse reactions might occur during the study; 6) Completed the study in accordance with the Protocol.
Exclusion criteria
Exclusion criteria: 1) People who had clinical laboratory test significantly abnormal, or other clinical findings - the following diseases (including but not limited to the gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, spirit or cardiovascular diseases); 2) People who had abnormal ECG; 3) People who had hepatitis (including hepatitis B and C), AIDS and syphilis screening positive; 4) People who had long history of smoking (within the 30 days before the study); 5) People who was explicitly allergic any ingredient of Sarpogrelate Hydrochloride Tablets in or its formulation ingredients; 6) People with history of drug and alcohol abuse; 7) People who donated blood or lost blood within 28 days before taking the study drugs(more than 450 mL); 8) People who took any drugs which changed the activity of liver enzymes within 28 days before taking the study drugs; 9) People who took any Rx or OTC drugs within 14 days before or during taking the study drugs; 10) People who took vitamin products or herbs within 14 days before taking the study drugs; 11) People who took any alcoholic products within 24h before taking the study drugs; 12) People who ate grapefruit or products containing grapefruit within 7 days before taking the study drugs; 13) People who took any food or drinks containing caffeine or xanthine within 48h before taking the study drugs; 14) People who took the study drugs or participated in any drug clinical trials within 3 months before taking the study drugs; 15) People who had difficulty for swallowing or history of any gastrointestinal diseases to affect drug absorption; 16) People who recently had major changes in diet or exercise habits; 17) People who had a medical emergency in the screening or before taking the study drugs; 18) People who had any hemorrhagic disease (VWD, capillary fragility disorders, gastrointestinal ulcers, urethral bleeding, hemoptysis, vitreous hemorrhage, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The pharmacokinetic parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety indicator; | — |
Countries
China
Contacts
Public ContactYanHua-Ding
Outcome results
None listed