Essential hypertension
Conditions
Interventions
Group 8:QR12000 compound tablets 300mg, fasting, oral, once a day for 7 days
Group 1:QR12000 compound tablets 37.5mg, fasting, oral, once a day
Group 2:QR12000 compound tablets 75mg, fasting, oral, once a day
Group 3:QR12000 compound tablets 150mg, fasting, oral, once a day
Group 4:QR12000 compound tablets 300mg, fasting, oral, once a day
Group 5:QR12000 compound tablets 450mg, fasting, oral, once a day
Group 6:QR12000 compound tablets 600mg, fasting, oral, once a day
Group 7:QR12000 compound tablets 150mg, fasting, oral, once a day for 7 days
Group 9:QR12000 compound tablets 450mg, fasting, oral, once a day for 7 days
Group 10:Placebo, same usage as the QR12000 compound tablets in the single administration study (Groups 1 to 6, 2 placebo cases in each group)
Sponsors
Beijing Tongren Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Healthy adult volunteers, between ages of 18 years old and 65 years old (including boundary values), male or female; 2. Weight >= 50 kg for male and weight >= 45 kg for female, Body mass index (BMI) between 19.0 kg/m2 and 26.0 kg/m2 (including boundary value); 3. Voluntary to participate and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who have a history of serious diseases of cardiovascular, respiratory, digestive, endocrine, or hematological systems, or who are currently suffering from the diseases mentioned above, or who have any other diseases that may interfere with the study results judged by the researchers; especially those who have a history of angioedema and / or bilateral renal artery stenosis; 2. Allergic to the study drug or any component of the study drug, or allergic constitution (refers to the body is prone to allergic reaction, or is allergic to a variety of food, drug, or environmental substances); 3. Those who have a history of postural hypotension or syncope, or hypertension; or who have a systolic blood pressure 140mmHg and / or diastolic blood pressure > 90mmHg; 4. Those who have a history of syncope when seeing needles or blood; 5. Vital signs, physical examination, laboratory examination (blood routine, coagulation function, blood biochemistry, urine routine), chest CT or chest X-ray examination, 12 lead ECG or other examinations are abnormal and have clinical significance during screening period; 6. HIV-P24 antigen / antibody, hepatitis C virus (HCV) antibody, or syphilis specific antibody is positive, or the five items of hepatitis B (HBsAg, HBsAb, HBeAg, HBeAb, and HBcAb) are abnormal and have clinical significance during screening period; 7. According to the dietary guidelines for Chinese residents, men who drink excessive alcohol more than 25 g per day, equivalent to 750 mL of beer, 250 ml of wine, 75 g of 38 degree liquor , or 50 g of high degree liquor; women who drink excessive alcohol more than 15 g per day, equivalent to 450 ml of beer, 150 ml of wine, or 50 grams of 38 degree liquor; 8. Those who smoked more than 5 cigarettes per day within 3 months before screening or could not stop smoking during the trial; 9. Urine screening of drug abuse (morphine, methamphetamine, ketamine, dimethylene dioxoamphetamine, tetrahydrocannabinol acid) is positive during screening period; 10. Those who have taken any drugs (prescription drugs, over-the-counter drugs, or Chinese herbal medicines) or health products within 2 weeks before screening; 11. Those who can't guarantee to take effective contraceptive measures for at least one year or who have pregnant plan; 12. Those who have participated in other clinical trials within 3 months before this trial; 13. Those who have lost or donated more than 200 mL blood within 3 months before this trial; 14. Those who have surgery history within 4 weeks before this trial or plan to have surgery before the completion of this trial; 15. Female subjects with positive pregnancy test or in lactation period; 16. Those who have taken any inducers or inhibitors of CYP2C9 enzyme within 1 month before this trial; 17. Those who have taken any substrates, inducers, or inhibitors of OATP1B1 or OATP1B3 transporters within 1 month before this trial; 18. Other situations that are evaluated by the researchers and are not suitable for this trial, or the subjects who are unable to participate in this trial due to their own reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety index;Pharmacokinetic parameter;Pharmacodynamics index; | — |
Countries
China
Contacts
Public ContactZhao Xiuli
Beijing Tongren Hospital Affiliated to Capital Medical University
Outcome results
None listed