coronary heart disease, angina
Conditions
Interventions
Postprandial group - Group 1(Group T-R):Oral administration of one tablet of test preparation after a high-fat, high-calorie meal in the first cycle,one tablet of the reference preparation after a hig
Postprandial group - Group 2(Group R-T):Oral administration of one tablet of reference preparation after a high-fat, high-calorie meal in the first cycle,one tablet of the test preparation after a hig
Sponsors
Zhejiang Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1) The subjects were fully aware of the purpose, nature, methods and possible adverse reactions of the trial, volunteered to serve as subjects, and signed an informed consent form before the start of any study procedure; 2) healthy subjects aged 18-60 years old (including 18 and 60 years old), both male and female; 3) body weight =50.0kg for men and =45.0kg for women; Body mass index (BMI) in the range of 19.0-26.0 kg/m2 (including critical value); 4) Vital signs, physical examination, clinical laboratory tests (blood routine, urine routine, blood biochemistry, infection, coagulation function, female blood pregnancy), 12-lead electrocardiogram, etc., with normal or abnormal results and no clinical significance; 5) The subjects had no plans to have children within 3 months from screening to the end of the trial, voluntarily took effective contraceptive measures, and had no plans to donate sperm and eggs.
Exclusion criteria
Exclusion criteria: 1) those with a history of allergy to isosorbide mononitrate or its excipients; Patients with a history of any drug or food allergy; 2) patients with a history of or existing serious cardiac, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, neurological, or psychiatric disease that was judged by the investigator to be ineligible for the trial; 3) patients with any history of gastrointestinal diseases affecting drug absorption; 4) patients with dysphagia; 5) patients with history of glaucoma; 6) patients with systolic blood pressure 8 cups, 1 cup =250 mL) per day in the previous 3 months; 19) those who cannot promise not to take dragon fruit, mango, grapefruit, lime, star fruit or food or drink prepared from them, chocolate and any beverage containing caffeine (such as coffee, strong tea, cola, etc.) during the first and second periods before admission to the phase I ward; 20) those with special dietary requirements or lactose intolerance (those with a history of cow's milk diarrhea) could not follow the uniform diet during the trial; 21) the female subjects were pregnant or lactating; 22) with alcohol breath test results greater than 0 mg/100mL during the study; 23) patients with acute illness before the initiation of the trial drug; 24) other conditions that were deemed ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum blood concentration of isosorbide mononitrate (Cmax);Area under the concentration-time curve from time 0 to the time point t at which plasma isosorbide mononitrate concentration can finally be determined(AUC0-t);Area under the blood concentration-time curve of isosorbide mononitrate from time 0 to infinity(AUC 0-8); | — |
Secondary
| Measure | Time frame |
|---|---|
| Peak time of isosorbide mononitrate(Tmax);elimination half-life(t1/2);Elimination rate constant(?z);Residual area percentage(AUC_%Extrap); | — |
Countries
China
Contacts
Public ContactWanggang Zhang
Zhejiang Hospital
Outcome results
None listed