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Conditions
Interventions
1:Valsartan and Amlodipine Tablets (I)
2:????????(I)
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) healthy male / female, aged 18 years and less than 45 years; (2) the body mass index of the subjects was between 19~26 (BMI), body mass index (BMI), body weight (kg) / height (m), and 2]; (3) the resting position systolic pressure of the subjects > 90mmHg and 60mmHg, and < 90mmHg; (4) physical examination (including physical examination, medical history, vital signs, ECG and clinical laboratory findings) was qualified and / or the investigators considered clinically abnormal and clinically insignificant. (5) willing to take no fertility plan during the test period and adopt non drug contraceptive measures (drug contraceptive measures, including oral contraceptives, contraceptives, subcutaneous implants, local contraceptives, such as anti sperm agents). For female subjects, pregnancy tests should be negative; (6) subjects should be able to read and understand the contents of informed consent, volunteer their subjects and sign informed consent.
Exclusion criteria
Exclusion criteria: (1) allergic to valsartan, amlodipine, or excipients; (2) before the first 3 months of the study, the daily smoking volume was more than 48 hours before the first 3 hours of the study. The tobacco users who had smoked or used any tobacco products within 48 hours before the first treatment were studied; (3) male weekly drinking alcohol history of more than 28 standard units of alcohol per week, women more than 21 standard units (1 units of 14g containing alcohol, such as beer or 360mL 45mL alcohol content 40% spirits or 150mL Wine), or 6 months before the test of regular drinking (weekly drinking more than 14 standard unit); (4) there was a history of drug abuse and / or positive screening for urine poisoning: screening of drug types: methamphetamine, MDMA, ketamine, morphine, heroin; (5) previous long-term drinking excess (above 2000ml) tea, coffee or caffeine containing beverages; on the first dose 48 hours before any intake of grapefruit, caffeine containing food or beverages (such as coffee, tea, chocolate, etc.); (6) with acute and chronic gastrointestinal diseases and heart, liver, kidney and other important organs diseases; diabetes, hyperthyroidism, Parkinson syndrome, or known to interference test results in any other diseases or physiological condition; (7) those who suffer from diseases of the blood system or have obvious bleeding tendency; (8) those with chronic mental disorders or mental disorders; (9) the use of any other drugs (including Chinese Medicine) within 2 weeks before the trial; (10) participated in other drug trials within 30 days before taking the test; (11) severe bleeding or donation of blood or plasma during the year prior to the start of the trial in March. (12) no effective contraceptive measures or pregnant or lactating women can be guaranteed during the test period. (13) abnormal blood pressure measurement, and / or orthostatic hypotension (postural hypotension: a change of position for the upright position within 3 minutes, a decrease in systolic blood pressure, diastolic blood pressure decreased, 20mmHg or 10mmHg, accompanied by low perfusion symptoms, such as dizziness or syncope); (14) the researchers found that subjects had other factors that were inappropriate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t;Cmax; | — |
Countries
China
Contacts
Public ContactXiang jin
West China Hospital, Sichuan University
Outcome results
None listed