heart failure
Conditions
Interventions
Group A (fasting state):T-R
Group B (fasting state):R-T
Group C (postprandial state):T-R
Group D (postprandial state):R-T
Sponsors
Shanghai Xuhui Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 18 years old = 50 kg, female >= 45 kg; body mass index (BMI) in the range of 19-26 kg / m2 (including 19 and 26 kg / m2); 3) No history of diseases such as heart, liver, kidney, digestive tract, nervous system, endocrine, mental abnormalities and metabolic abnormalities, No history of preparation allergies, no history of serious infections and serious injuries; 4) Physical examination, vital signs measurement, electrocardiogram examination, and laboratory examination are all important or normal. Within the scope deemed acceptable by the organizer / researcher; 5) During the test and within 3 months after the last medication, there is no parenting plan and reliable contraceptive measures can be taken; 6) Fully understand the purpose and requirements of this trial, voluntarily participate in clinical trials and sign written informed consent, complete all test procedures according to test requirements.
Exclusion criteria
Exclusion criteria: Excludes if any of the following are met: 1) Known to have a history of allergies, allergic diseases or allergies to the test preparation and any of its ingredients or related preparations; 2) Those with a clear medical history of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, endocrine system, metabolic disorders, etc. or other diseases that are not suitable for clinical trials (such as history of mental illness, etc.); 3) For subjects with orthostatic hypotension, orthostatic hypotension is defined as standing up in the supine position for at least 5 minutes, with a decrease in systolic blood pressure > 20 mmHg or diastolic blood pressure> 10 mmHg within the first 3 minutes; 4) Before screening, there are abnormal conditions such as history of syncope, palpitations, bradycardia, tachycardia (such as any degree of conduction block, left bundle branch block, right bundle branch block); 5) Those who have donated blood or lost blood >= 400 mL within 3 months before enrollment; 6) Those who have used any prescription drugs, non-prescription drugs, Chinese herbal medicines, health products within 30 days before the first administration; 7) Those who have participated in clinical trials of other drugs within 3 months before being selected; 8) Those who have a history of drug abuse, a history of drug dependence, or a positive drug screen (morphine, dimethyldioxyamphetamine, methamphetamine, tetrahydrocannabinol, ketamine, cocaine); 9) Alcohol breath test result is positive, or current or past alcoholics (drinking more than 14 standard units per week. 1 standard unit contains 14 g alcohol, such as 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine); 10) People who smoke more than 10 cigarettes per day; 11) Hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), syphilis antibody positive; 12) Abnormal chest radiograph results and clinical significance; 13) Positive pregnancy test (for women); 14) The researchers believe that there are other factors that are not suitable for participating in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug concentration in blood;AUC0-t, AUC0-8, Cmax; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax, t1/2, ?z;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactJingying Jia
Shanghai Xuhui Central Hospital
Outcome results
None listed