mild to moderate essential hypertension
Conditions
Interventions
Valsartan Capsules(Producted by China Resources Saike Pharmaceutical Co.,Ltd.):1 capsule was dosed in each cycle/each subject, total 3 cycles.
Valsartan Capsules(Producted by Novartis):1 capsule was dosed in each cycle/each subject, total 3 cycles.
Sponsors
First Hospital of Jilin University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. prior to the trial, the informed consent was signed, and the content process and possible adverse reactions were fully understood; 2. be able to complete the research according to the requirements of the test plan; 3. Subjects (including partners) volunteered to take effective contraceptive measures without pregnancy plan within 6 months from the first 2 weeks before study to the last study drug week to the last study drug week. The specific contraceptive measures are listed in Appendix 5; 4. men and women aged 18~50 years (including 18 and 50 years); 5. 5 the weight of male subjects was not less than 50 kg, and the weight of female subjects was not less than 45 kg. Body mass index (BMI) = body weight (kg) / height 2 (m2), and body mass index (BMI) ranges from 18.0 to 28.0 kg/m2 (including the critical value); 6. physical examination and vital signs are not clinically significant.
Exclusion criteria
Exclusion criteria: 1. the number of smokers who smoked more than 5 cigarettes in the first 3 months before the test; 2. Has allergic history to test drugs or any other excipient in this book, allergic constitution (multiple drugs and food allergies); 3. History of alcoholism (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); 4. blood donation or massive loss (>450mL) within three months prior to screening; 5. any drugs that alter the activity of liver enzymes were taken on the 28 day before screening; 6. take any prescription drugs, OTC drugs, any vitamin products or herbs within 14 days before the screening 7. Those who had taken special diet (including grapefruit, etc.) or had vigorous exercise or other factors affecting drug absorption, distribution, metabolism and excretion within 2 weeks before screening; 8. there have been major changes in eating habits or exercise habits recently; 9. during the first three months before taking the research drug, he passed or participated in the clinical trial. 10. having history of dysphagia or any gastrointestinal disease affecting drug absorption; 11. suffering from any increased risk of bleeding, such as hemorrhoids, acute gastritis or duodenal ulcer; 12. Subjects who could not tolerate a standard meal (two boiled eggs, a slice of buttered bacon toast, a box of chips, a glass of whole milk); 13. abnormal ECG has clinical significance; 14. in the screening period or in the process of examination, the female subjects were in the lactation serum pregnancy outcome Yang; 15. Abnormal clinical laboratory examinations (especially electrolytes, creatinine and urea nitrogen indicators) have clinical significance, or other clinical findings that show clinical significance in the following diseases (including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumors, lung, immune, mental or cardio-cerebrovascular diseases); 16. Those with severe headache, migraine history or history of orthostatic hypotension, or those with orthostatic hypotension at screening time; 17. viral hepatitis (including hepatitis B and hepatitis C), AIDS antibody, syphilis spiral antibody screening positive; 18. from screening phase to acute diseases before or after taking drugs, or having combined medication; 19. Chocolate, any caffeine-containing or xanthine-rich foods or beverages were consumed 48 hours before taking the study drug; 20. take any alcoholic products within 48 hours before taking the research medicine; 21. urine screening positive or in the past five years there is a history of drug abuse or drug users; 22. the researchers believe there are other subjects who are not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8;Tmax;t1/2;?z; | — |
Countries
China
Contacts
Public ContactZhang Guocheng
the First Hospital of Jilin University
Outcome results
None listed