hypertension
Conditions
Interventions
Group A:In the fasting test, the test preparation was administered in the first cycle, and after 7 days of washing, the reference preparation was administered in the second cycle
Group C:In the postprandial test, the test preparation was administered in the first cycle, and after 7 days of washing, the reference preparation was administered in the second cycle
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Group B:In the fasting test, the reference preparation was administered in the first cycle, and after 7 days of washing, the test preparation was administered in the second cycle
Sponsors
The Second Affiliated Hosptial of Xingtai Medical College
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Gender: Chinese healthy male or female subjects with appropriate gender ratio; 2. Age: over 18 years old (including 18 years old); 3. Male subjects should not be less than 50.0kg, female subjects should not be less than 45.0kg, and body mass index (BMI): 19.0~26.0kg/m2 (including boundary values, body mass index (BMI) = body weight ( kg) / height 2 (m2)); 4. Subjects must give informed consent to this study before the trial, and voluntarily sign a written informed consent; 5. The subjects or their partners must be willing to use medically acceptable contraceptive methods within 6 months from the signing of the informed consent form to the end of the trial; 6. The subject can communicate well with the investigator and complete the study in accordance with the protocol.
Exclusion criteria
Exclusion criteria: 1. Allergic constitution or history of drug or food allergy, or known allergy to any component of this product (such as olmesartan medoxomil); 2. The investigator considers clinically significant liver, kidney, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal (such as peptic ulcer disease), lung, tumor, immune, facial, skin, reproductive, blood, or metabolism Diseases such as disorders or any other disease, or have a history of these diseases, or have had a history of major surgery, or factors that would compromise the safety of the subject or affect the results of the study; 3. Physical examination, vital signs measurement, laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function, blood pregnancy (only for female subjects), serum virology), 12-lead electrocardiogram results according to the investigator's judgment Abnormalities are clinically significant; 4. From 30 days before administration to 6 months after the end of the study, the subject (or his partner) has a pregnancy plan, or the subject has a sperm or egg donation plan; 5. Pregnant, breastfeeding women, or women of childbearing age who did not take appropriate contraceptive measures within 14 days before enrollment, or who used oral contraceptives within 30 days before the first dose of the study, or who used long-acting estrogen or progesterone within 6 months before the test Injectable or embedded tablet; 6. Have a history of drug abuse, or positive results of drug abuse and drug testing (morphine, methamphetamine, ketamine, MDMA, THC, cocaine); 7. Taking any prescription drugs, non-prescription drugs, health products or Chinese herbal medicines within 14 days before screening; 8. Excessive smoking (>=5 cigarettes/day) within 6 months before screening, or smoking within 48 hours before the first dose of the study, or smoking cannot be discontinued during the trial; 9. Drinking more than 14 standard units per week within 3 months before screening (1 standard unit contains 14g alcohol, such as 360mL beer or 45mL spirits with 40% alcohol content or 150mL wine), or alcohol breath test result is greater than 0.0 mg/100mL, or alcohol abstinence cannot be accepted during the trial; 10. Long-term drinking of excessive caffeinated beverages (more than 8 cups a day, 1 cup = 250mL), or intake of any caffeinated food or beverage within 48 hours before the first dose of the study (such as coffee, tea, cola, chocolate) etc.), or the intake cannot be interrupted during the test; 11. Within 48 hours before the first dose of the study, take any grapefruit fruit or products containing grapefruit, or the intake cannot be interrupted during the test; 12. There are special requirements for diet and cannot comply with the unified diet; 13. Have started a significantly abnormal diet (such as diet, low sodium) within 4 weeks before screening; 14. Participated in other clinical trials within 3 months before screening; 15. Have been vaccinated within 1 month before screening; 16. Blood donation or massive blood loss (>=200mL) within 3 months before screening; 17. Difficulty in obtaining venous blood, or unable to tolerate venipuncture, or have a history of fainting and fainting; 18. Any other factors that the investigator considers unsuitable for subjects to enter this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum blood concentration;The area under the plasma concentration-time curve from 0 to the last time point t(AUC0-t);Area under the plasma concentration-time curve from zero to infinity(AUC0-8); | — |
Countries
China
Contacts
Public ContactGuo Fengxue
The Second Affiliated Hosptial of Xingtai Medical College
Outcome results
None listed