None listed
Conditions
Interventions
Group A:From D1 to D7, 75mg clopidogrel is taken orally once a day. From D18 to D24, 75mg clopidogrel and 10mg Ilaprazole are administered orally once a day.
Group B:From D1 to D7, 75mg clopidogrel and 10mg Ilaprazole are administered orally once a day.From D18 to D24, 75mg clopidogrel is taken orally once a day.
Sponsors
The First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Patients who voluntarily participate in the clinical trial after fully understanding the contents of the trial and possible adverse reactions, and sign the informed consent in writing; 2. 18-55 years old (including boundary value), both male and female; 3. Male body weight >= 50kg, female body weight >= 45kg, and body mass index (BMI) 19.0-26.0kg/m2 (including boundary value); 4. Health status: there were no clinically significant abnormal vital signs, physical examination, laboratory examination, 12 lead ECG and other examination results at screening and baseline; 5. Patients who can maintain good communication with researchers and comply with the requirements of clinical trials.
Exclusion criteria
Exclusion criteria: 1. Subjects with a history or constitution of allergy or known to be allergic to any component of the study drug; 2. Pregnant and lactating women; patients who are not willing to take effective contraceptive methods within 6 months after signing the informed consent to the last administration of the test drug; subjects who have family planning within half a year after the end of the test; 3. The subjects who have difficulty in venous blood collection or are dizzy with acupuncture and blood; 4. Subjects with dysphagia or any gastrointestinal diseases (such as nausea, diarrhea, vomiting, inflammatory bowel disease, acute gastroenteritis, peptic ulcer, etc.) and affecting drug absorption; 5. Patients who frequently smoke or drink alcohol (more than 5 cigarettes / day, more than 21 units of alcohol per week, 1 unit = 360 ml of beer or 45 ml of white wine or 150 ml of wine) within 3 months before screening, or who cannot stop using any tobacco products or alcohol intake during the study period, or who are positive in alcohol breath test before enrollment; 6. Subjects who had a history of drug abuse within 12 months prior to screening, or found evidence of such abuse in screening or baseline evaluation; 7. Subjects who have participated in clinical studies of other drugs or devices within 3 months before screening; 8. The subjects with blood donation or blood loss greater than 200ml within 3 months before screening; 9. Subjects who took any prescription drug, over-the-counter drug, herbal medicine or health care product within 14 days before taking the study drug; 10. Patients who took any drug that changed the activity of liver enzyme 28 days before taking the study drug, or other subjects who affected the absorption, distribution, metabolism, excretion and other factors of the drug; 11. Subjects who had eaten food or drink (such as grapefruit) containing enzymes that can induce or inhibit liver metabolism within 7 days before taking the study drug; subjects who had eaten chocolate, any food or drink containing caffeine or rich in xanthine 48 hours before taking the study drug; 12. In screening, the patients with HIV antibody, hepatitis B surface antigen, hepatitis C antibody and Treponema pallidum specific antibody were positive; 13. Patients with diseases or disease history that need to be excluded due to abnormal clinical manifestations, including but not limited to nervous system, cardiovascular system, kidney, liver, respiratory system, metabolism and skeletal system diseases; 14. Subjects who have special requirements on diet and cannot follow the unified diet arrangement; 15. Other factors considered unsuitable by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax,ss, Cmin,ss, Cav,ss, Tmax,ss, AUCtau,ss, T1/2, CL/F, Vz/F; | — |
Secondary
| Measure | Time frame |
|---|---|
| MPA, PRI; | — |
Countries
China
Contacts
Public ContactFeng Shao
The First Affiliated Hospital of Nanjing Medical University
Outcome results
None listed