Pharmacokinetic study
Conditions
Interventions
emptiness group:Order and dose of administration
Postprandial test group:Order and dose of administration
Sponsors
Dongyang Hengdian Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Healthy adult males and non-pregnant non-lactating females aged between 18 and 55 (including 18 and 55 years old, but not excluding those over 50 years old); 2.Male weight >=50kg, female weight >=45kg, body mass index (BMI) between 19 and 28kg/m^2, including boundary value; 3.In good health, with a history of arrhythmia, liver, kidney, digestive tract, nervous system, mental disorders and metabolic diseases; 4.Sign informed consent before the test, fully understand the test content, process and possible adverse reactions, and be able to communicate well with researchers.
Exclusion criteria
Exclusion criteria: 1.Participated in other clinical trials within 90 days before the study, or plan to participate in other clinical trials during the study; 2.Subjects who had major surgery within 90 days before this trial, or plan to surgery 3 months after the trial; 3.Blood donation or massive blood loss (>300 mL, excluding female physiological period), or received blood transfusion within 90 days before this trial; 4.Subjects with gastrointestinal diseases such as esophageal reflux, stomach bleeding or peptic ulcer disease, heartburn occurs more than once a week, or any surgical procedure that may affect drug absorption (such as cholecystectomy) within 180 days; 5.Subjects who have a history of specific allergies (such as asthma, urticarial and eczema), or allergy to two or more kind of drugs, food and pollen, or allergy to any components of this preparation or similar species; 6.Taking any medicines, including prescription, over-the-counter and/or alternative medicines (such as medicinal diet, Chinese herbal medicine, hemostatic or health care products) and hormonal contraception or vaccines within 28 days prior to the trial; 7.A history of psychotropic substance abuse; 8.Positive result of urine screening test of drug abuse (tetrahydrocannabinolic acid, benzodiazepines, barbiturates, morphine, cocaine, methamphetamine); 9.Subjects who smoke more than 5 cigarettes per day 90 days before the study, subjects who drink frequently 28 days before the study, that is, drinking more than 7 units of alcohol (female)or 14 units of alcohol(males) per week (1 unit =150 mL of wine =360 mL of beer = 45 mL of alcohol); 10.Positive result of alcohol breathing test results; 11.Body temperature (ear temperature) >=37.5 degree, respiratory abnormalities were obvious and the researchers considered that the patients were not suitable for the study, sitting systolic blood pressure >140mmHg or 90mmHg or 100 beats/min; 12.Positive for human immunodeficiency virus (HIV-AB), hepatitis B surface antigen (HBsAg), hepatitis C (anti-HCV) or syphilis antibody (TP); 13.Subjects who have special requirements for diet, and cannot comply with a unified diet; 14.Subjects who take beverages and foods containing caffeine, alcohol or grapefruit (including tea, chocolate, coffee and cola) within 48h before taking the study drug; 15.Subjects with partners refuse to use effective contraception within 180 days from screening to completion of the study; 16.Female subjects have positive result of pregnancy test; 17.Subjects with liver insufficiencyrenal impaired or urinary system disorder; 18.Subjects with severe hypotension or history of orthostatic hypotension; 19.Dizziness of needles, dizziness or difficulty in venous blood collection; 20.There are obvious abnormalities in the physical examination and the investigator considers that they are not suitable for the study; 21.There are obvious abnormalities in electrocardiogram examination and the researcher considers that they are not suitable for the study; 22.There are obvious abnormalities in blood biochemistry, blood routine examination and urine routine examination and the researcher considers that they are not suitable for the test; 23.Subjects may not be able to complete the study for other reasons or may be deemed unsuitable for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak concentration;Area under the drug-time curve from zero to t;Area under the drug-time curve from zero to infinity; | — |
Countries
China
Contacts
Public ContactChen Liping
Dongyang Hengdian Hospital
Outcome results
None listed