Study to Assess Pharmacokinetics, Pharmacodynamics and Safety of Tiprogrel in Healthy Subjects

Korábbi kezelés

• Subjects who had a history of major surgery within 3 months before the trial or planned to undergo surgery during the study period.
• Subjects who have lost or donated ≥ 400 mL blood or received blood transfusion or used blood products within three months, or subjects with clinically significant anemia based on the judgment of the Investigator
• Subjects who have taken aspirin/other nonsteroidal anti-inflammatory drugs (NSAIDs) or other drugs that may affect coagulation function within 2 weeks before the trial
• Subjects who have taken prescription drugs/products or herbs within 2 weeks or 5 half-lives (whichever is longer) before the trial;or taken OTC drugs/products within 7 days before the trial.
• Subjects who have received live or attenuated vaccines within 1 month prior to receiving the study drug or expected to receive vaccines during the study period
• Subjects who have ingested investigational drug within 3 months or 5 half-lives prior to the first study drug dose
• Subjects who have participated in another clinical trial within 3 months or 5 half-lives prior to the first study drug dose;
• Consumption of any known liver enzyme inducers/inhibitors within 30 days prior to the first study drug dose;
• Have a history of drug addiction or drug abuse within 1 year prior to screening;
• Positive results for alcohol, or cotinine, or urine for drugs test in screening or admission;
• Use of tobacco or nicotine-containing products within 1 month prior to screening;

Más betegség

• History or presence of metabolic, allergy, dermatology, liver, kidney, hematology, cardiovascular, gastrointestinal, nervous, respiratory, endocrine or psychiatric diseases.
• History or presence of obviously active bleeding, or coagulation or bleeding disorders, or any skin petechiae, or thrombus, or spontaneous bleeding.
• Subjects with positive results at screening for HIV, syphilis, HBsAg, or HCV
• Subjects with a history of fainting needle or blood;

Laborértékek

• Subject with history of allergy to a variety of drugs, or has a known or suspected hypersensitivity to tiprogrel or other anti-platelet drugs
• Platelet count (PLT) value, beyond the laboratory's reference range
• Activated partial thromboplastin time (APTT) and Prothrombin Time (PT), beyond the laboratory's reference range
• ALT, AST, γ-GGT, ALP and TBIL value >1.5 times the upper limit of normal value

Egyéb

• Subjects with systolic blood pressure of > 140 mmHg or < 90 mmHg, diastolic blood pressure of > 90 mmHg or < 60 mmHg
• Subjects with 12-lead ECG examination: QTcF > 450 msec
• Subject with alcohol consumption defined as > 21 units per week for men and > 14 units per week for woman;
• CYP2C19 poor metabolizer;
• Subjects who are not suitable to participate in this experiment.

• Male and female Healthy Subjects
• Subject has the ability and willingness to comply with study procedures and follow-up examination.
  • 3：18 to 50 years of age (including the threshold) 4: Body mass index (BMI) ≥ 19.0 to ≤ 28.0 kg/m2; total body weight of male subject ≥ 50 kg at Screening; total body weight of female subject ≥ 45 kg at Screening; 5：Medically healthy based on their medical history, and physical examination, clinical laboratory test results, ECGs, and vital sign measurements as determined by the Investigator at Screening; 6: Female subjects are not pregnant or breastfeeding, and the fertile female and male subjects must agree to follow instructions for method(s) of contraception.