Hypertension in all stages
Conditions
Interventions
fasting control group:R-T-R-T
postprandial control group:R-T-R-T
Fasting experimental group:T-R-T-R
Postprandial test group:T-R-T-R
Sponsors
Huzhou Central Hospital, Zhejiang Province
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. The subjects fully understand the purpose, nature, methods and possible adverse reactions of the research, volunteer as subjects, and sign the informed consent form before any experimental procedure begins; 2. The age is over 18 years old (including 18 years old) male or female healthy subjects; male weight = 50.0 kg, female weight = 45.0 kg; body mass index (BMI) in the range of 19.0 ~ 26.0 kg/m2 (including cutoff values), body mass index (BMI) = body weight (kg )/height 2 (m2); 3. The subjects can communicate well with the investigator, and understand and comply with the requirements of this trial. Those who do not meet one of the above conditions shall not be selected as subjects.
Exclusion criteria
Exclusion criteria: 1. Those who have a history of specific allergies (urticaria, etc.), or allergic constitution (such as those who are allergic to two or more drugs, foods such as milk and pollen), or those who are known to be allergic to any component of this drug or sulfonamide derivatives; 2 . Diseases that have occurred or are occurring before screening and are clinically significant (as determined by the doctor) that need to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, Patients with respiratory, metabolic and skeletal diseases; 3. Patients with a history of angioedema and hypotension; 4. Patients with dysphagia or any history of gastrointestinal diseases that affect drug absorption (such as inflammatory bowel disease, gastritis, ulcers, History of colitis, rectal bleeding, persistent nausea or other gastrointestinal abnormalities); 5. Have undergone surgery that has been judged by the study physician to affect drug absorption, distribution, metabolism and excretion before screening, or plan to undergo surgery during the trial 6. Those who have used any drugs that change the gastrointestinal environment within 30 days before screening (such as proton pump inhibitors tetoprazole, omeprazole, lansoprazole, esoprazole, etc.; H2 antagonists Nitidine, cimetidine, famotidine, etc.; antacids sodium bicarbonate, magnesium oxide, aluminum hydroxide, magnesium trisilicate, etc.; gastric mucosal protective agent sucralfate, etc.); 7. Before screening Those who have used any drug that interacts with valsartan and hydrochlorothiazide within 30 days, such as non-steroidal anti-inflammatory drugs (such as salicylic acid derivatives, indomethacin), anticholinergic drugs (such as atropine, biperide) Deng), furosemide, corticosteroids, adrenocorticotropic hormone, cyclosporine, calcium preparations, lithium preparations, ACE inhibitors, and other thiazide diuretics, etc., see Scheme 1.2.10 for details; 8. Before screening Those who have used any prescription drugs, non-prescription drugs, Chinese herbal medicines and health products within 2 weeks; 9. Smoking = 5 cigarettes per day within 3 months before screening, or disagree or cannot stop during the trial (from the screening date to the end of the trial) Those who use any tobacco-containing products; 10. Weekly alcohol consumption = 14 units within 3 months before screening (1 unit of alcohol ˜ 285 mL of beer or 25 mL of spirits with an alcohol content of 40% or 100 mL of wine), or during the trial (since During the period from the screening date to the end of the trial) who do not agree or cannot stop using any alcohol-containing products; 11. Those who have used drugs within 12 months before screening; 12. Those who have a history of drug abuse within 12 months before screening; 13 . Participated in other drug clinical trials within 3 months before screening; 14. Donated blood including blood components or massive blood loss (>400mL) within 3 months before screening, received blood transfusion or used blood products, or planned to end the trial 15. Those who have been vaccinated within one month before screening or who plan to receive vaccination within one month after the end of the trial; 16. Those who have eaten food containing enzymes that can induce or inhibit liver metabolism within 7 days before screening Foods (such as grapefruit, grapefruit, lime, etc.) and their prepared foods or beverag
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;Auc;Tmax;t 1/2;Adverse events; | — |
Countries
China
Contacts
Public ContactYang Shuixin
Outcome results
None listed