Pharmacokinetic study
Conditions
Interventions
Experimental group1:Fasting test
Experimental group2:Postprandial test
Sponsors
Dongyang Hengdian Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Chinese healthy volunteers aged 18 to 55 years, both men and women; 2. Male subjects weigh not less than 50 kg, female subjects weigh less than 45 kg; body mass index (BMI) ranges from 19 to 28 kg/m2 (including cut-off values); 3. Subjects are healthy, no history of heart, liver, kidney, digestive tract, nervous system, mental disorders and metabolic diseases; 4. Sign the informed consent form before the trial and fully understand the test content, process and possible adverse reactions. Volunteers are 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.Treatment of any medicine (including medicated diet, Chinese herbal medicine, hemostatic and blood-activating plants and health products) and hormone or vaccines or non-selective monoamine oxidase (MAO) inhibitors within 28 days before the study; 7.Drug abuse history; 8.Positive result of urine screening test (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.temperature (ear temperature) >= 37.5?, Obviously abnormal breathing according to the physician's judgment, systolic blood pressure > 140mmHg or 90mmHg or 100 bpm; 12.Positive result of HIV-AbHBsAgHCVTP test; 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) or iron-added products (such as milk powder or enteral nutrition) 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 renal impaired or urinary system disorder; 18.Dizziness of needles, dizziness or difficulty in venous blood collection; 19.Obvious abnormalities in physical examination and according to the physician's judgment; 20.Obvious abnormalities in the electrocardiogram according to the physician's judgment; 21.Obvious abnormalities in blood biochemistry, blood routine, and urine routine examinations according to the physician's judgment; 22.Subjects with severe cardiovascular disease, lung disease, bronchial asthma, kidney disease, liver disease, endocrine disease or subjects with a history of convulsions; 23.Subjects with angle-closure glaucoma; 24.Subjects with suspected skin damage or a history of melanoma; 25.Subjects with atrial, nodal or ventricular arrhythmia, and recent history of myocardial infarction; 26.Subjects with other reasons cannot complete the researchers according to the physician's judgment..
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak concentration;Area under drug-time curve0-t;Area under drug-time curve0-8; | — |
Countries
China
Contacts
Public ContactChen Liping
Dongyang Hengdian Hospital
Outcome results
None listed