Cardiovascular disease
Conditions
Interventions
Sponsors
Beijing Shijitan Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Demography: I 01.Healthy Chinese male or female subjects, 18 years of age or older; I 02.Body weight between 50.0 and 95.0 kg inclusive for male, 45.0 and 90.0 kg inclusive forfemale.Bodymass index (BMI) between 18.5 and 27.9 kg/m2, inclusive; Health status: I 03.Certified as healthy by a comprehensive clinical assessment (detailed medical history andcomplete physical examination); I 04. Normal vital signs after 10 minutes resting in seated or supine position: - 90 mmHg = systolic blood pressure (SBP) 30 IU/L; Regulations: I 08. Having given written informed consent prior to undertaking any study-related procedure; I 09. Not under any administrative or legal supervision.
Exclusion criteria
Exclusion criteria: Medical history and clinical status: E 01. Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal,hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular,psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs ofacute illness; E 02. Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only:more than twice a month). E 03. Blood donation any volume or blood loss volume >200 mL, within 3 months beforeinclusion; E 04. Symptomatic postural hypotension, irrespective of the decrease in blood pressure, orasymptomatic postural hypotension defined as a decrease in SBP =20 mmHg within3 minutes when changing from supine to standing position; E 05. Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by aphysician; E 06. History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per dayon a regular basis); E 07.Smoking more than 5 cigarettes or equivalent per day within 3 months before inclusion,unable to stop smoking during the study; E 08. Excessive consumption of beverages containing xanthine bases (more than 4 cups orglasses per day); E 09.If female, pregnancy (defined as positive beta human chorionic gonadotropin [ß-HCG]blood test), or breast-feeding; Interfering substance: E 10. Any medication (including traditional Chinese medicine or herbal supplements such as StJohns Wort) within 14 days before inclusion or within 5 times the elimination half-life orpharmacodynamic half-life of the medication, with the exception of hormonalcontraception or menopausal hormone replacement therapy; any vaccination within the last28 days and any biologics (antibody or its derivatives) given within 4 months beforeinclusion; General conditions: E 11. Any subject who, in the judgment of the Investigator, is likely to be noncompliant during; the study, or unable to cooperate because of a language problem or poor mental development; E 12. Any subject in the exclusion period of a previous study; E 13. Any subject who cannot be contacted in case of emergency; E 14. Any subject who is the Investigator or any subinvestigator, research assistant, pharmacist,study coordinator, or other staff thereof, directly involved in conducting the study; Biological status: E 15. Positive result on any of the following tests: hepatitis B surface antigen (HBs Ag), antihepatitisC virus (anti-HCV) antibodies, anti-human immunodeficiency virus (anti-HIV)antibodies and Treponema pallidum antibody (TP-IgG); E 16. Positive result on urine drug screen (methamphetamines, barbiturates, ketamine,cannabinoids, cocaine, opiates); E 17.Positive alcohol test; Specific to the study: E 18.Any consumption of citrus fruits (grapefruit, orange, etc.) or their juices within 5 days before inclusion.Contraindications; E 19. Any contraindication to clopidogrel or ASA such as: - Presence or history of a hypersensitivity to clopidogrel, ASA or nonsteroidalanti-inflammatory drug products (NSAIDs);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Pressure;Pulse;Temperature;ECG;Blood Routine Examination;Routine Urine Examination;Blood Biochemical; | — |
Countries
China
Contacts
Public ContactXinghe Wang
Beijing Shijitan Hospital Capital Medical University
Outcome results
None listed