Pharmacokinetic study
Conditions
Interventions
first goup:the reference preparation was given on an empty stomach in large size
second group:the test preparation was given on an empty stomach in large size
third group:the reference preparation was given on an empty stomach in small size
fourth group:the test preparation was given on an empty stomach in small size
group A:the reference preparation was given after meals in large size
group B:the test preparation was given after meals in large size
group C:the reference preparation was given after meals in small size
group D:the test preparation was given after meals in small size
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 and non-lactating females aged 18 to 55 years (including 18 and 55 years of age, the experiment period over 55 years of age is not excluded); 2.Male subjects weighing no less than 50 kg, female subjects weighing no less than 45 kg; body mass index (BMI) ranges from 19 to 28 kg/m^2 (including cut-off values); 3.Subjects are healthy, non heart, liver, kidney, digestive tract, nervous system, mental disorders and metabolic diseases etc., medical history judged by the investigator to have an impact on this study; 4.Sign the informed consent form before the trial and fully understand the test content, process and possible adverse reactions. Subjects 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 with a history of specific allergies (such as asthma, urticaria, eczema, etc.), or allergy to two or more kinds of drugs, food and pollen, or allergy to any components of this preparation or similar ingredients; 6.Use of any medicines, including prescription, over-the-counter and/or alternative medicines (such as medicated diet, Chinese herbal medicine, hemostatic or health care products), 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 (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?, 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.Human immunodeficiency virus (HIV-AB), hepatitis B surface antigen (HBsAg), hepatitis C (anti-HCV) and syphilis antibody (TP) are positive; 13.Have special requirements on diet, and cannot follow the uniform diet during the test; 14.Subjects who can not obey the management that they can not take beverages and foods containing caffeine, alcohol or grapefruit(grapefruit juice) (including tea, chocolate, coffee and cola, etc.) 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.Dizziness of needles, dizziness or difficulty in venous blood collection; 18.Have obvious abnormalities on the physical examination and are deemed by the investigator to be unfit for the study; 19.There are obvious abnormalities in electrocardiogram and the investigator considers that they are not suitable for the study; 20.There were obvious abnormalities in blood biochemistry, blood routine examination and urine routine examination, and the researcher considered that they were not suitable for the study; 21.Subjects may not be able to complete the study for other reasons or may be deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main pharmacokinetic parameters;Safety evaluation index; | — |
Countries
China
Contacts
Public ContactJIn Feiyan
Dongyang Hengdian Hospital
Outcome results
None listed