Hypertension, coronary heart disease
Conditions
Interventions
Test Product-Reference Product (fasting):On the first day of the trial (cycle I), the test preparation was taken orally on an empty stomach
on the 15th day (cycle II) in the morning, the subjects took the reference preparation orally on an empty stomach
Reference Product-Test Product (fasting):On the first day of the trial (cycle I), the reference preparation was taken orally on an empty stomach
on the 15th day (cycle II) in the morning, the subjects took the test preparation orally on an empty stomach
Reference formulation-Test product (after meal):On day 1 (cycle I), reference preparation was taken orally after meal, and on day 15 (cycle II) in the morning, subjects took test preparation orally af
Test product-Reference formulation (after meal):On day 1 (Cycle I), the test preparation was taken orally after meal, and on day 15 (cycle II) in the morning, the subjects took the reference preparati
Sponsors
Cangzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form; 2. Male or female, aged at 18 years old; 3. The male body mass shall not be less than 50.0 kg, and the female body mass shall not be less than 45.0 kg; 4. Physical examination, vital signs examination, laboratory examination (blood routine, urine routine, liver function, renal function, blood glucose), 12-lead electrocardiogram examination, chest X-ray examination results have normal or abnormal clinical significance; 5. Female blood pregnancy test results are negative; 6. Serological examination (hepatitis B surface antigen, hepatitis C antibody, syphilis-specific antibody, AIDS antibody) with normal results; 7. Negative breath alcohol test results; 8. Urine drug screening (morphine, methylamphetamine, ketamine, dimethylene bisphetamine, tetrahydrocannabinolic acid) results were negative.
Exclusion criteria
Exclusion criteria: 1. Allergy constitution or have a history of drug allergy; 2. A history of any disease that may affect the safety of the test or the course of the drug; 3. Any history of surgery or trauma that may affect the safety of the test or the in vivo process of the drug; 4. Any current unstable or recurrent disease, or a disease that affects the internal process of the drug; 5. A history of drug abuse and dependence in the past 2 years; 6. Any drug used within 14 days before the trial; 7. Smoking addiction (smoking 10 or more cigarettes per day) or not smoking smoking during the test; 8. Alcohol consumption (drinking more than 2 units per day, more than 14 units of alcohol per week, 1 unit = 360 mL beer or 45 mL alcohol 40% alcohol or 150 mL wine) or alcohol within 48 h prior to the trial; 9. Participated in other drug clinical trials within 90 days before the trial; 10. Any blood loss or blood donation of 200 mL or more within 90 days before the test; 11. Have a history of dizzy acupuncture or blood sickness; 12. Lactating women; 13. Family planning, unwillingness or inability to take effective contraceptive measures within 30 days before the test to half a year after the end of the trial; 14. Unable to communicate or cooperate with medical staff due to neurological, mental illness or language disorders; 15. Under other circumstances, the investigator considers not inappropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak concentration;0 to 72 hours to the time curve; | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical examination;Vital sign examination;Laboratory examination;12 lead electrocardiogram test;Adverse event;Adverse reaction; | — |
Countries
china
Contacts
Public ContactWang Yanrong
Outcome results
None listed