Pharmacokinetics and coefficient of variation in human body
Conditions
Interventions
Fasting group A:Cycle I: drug t under trial production: cycle II: reference drug R
Fasting group B:Cycle I: reference preparation R: cycle II: test preparation t
Sponsors
Wuhan Xiangfang clinical pharmacology research center
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged 18-65 (including 18 and 65 years old) with appropriate sex ratio; 2. Body weight: not less than 50 kg for men, not less than 45 kg for women, body mass index (BMI) [= weight (kg) / height 2 (M2)] between 19 and 26 (including boundary value); 3. Systolic blood pressure 90 to 140 mmHg, diastolic blood pressure 60 to 90 mmHg, pulse 50 to 100 times / min; 4. Patients who have known the nature, significance, possible benefits, inconvenience and potential danger of the trial in detail before the trial, voluntarily participate in the clinical trial, have good communication with researchers, comply with the requirements of the whole study, and sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. (inquiry) Patients who have a history of drug abuse, obvious tobacco and alcohol addiction and / or dependence on other substances (such as betel nut); 2. Patients who have participated in clinical trials of other drugs within 3 months; 3. (inquiry) Patients with diseases that need to be excluded due to abnormal clinical manifestations, including but not limited to nervous system, cardiovascular system, blood and lymph system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism and bone system diseases; 4. (inquiry) Patients who have a history of severe vomiting, diarrhea or any other disease or physiological condition that can interfere with the test results within 7 days before the test; 5. (inquiry) The patient who has a history of allergy to penicillin, himself or his parents or brothers, has the constitution of allergic symptoms such as bronchial asthma, rash, urticaria, etc; 6. (inquiry) Subjects who lost blood or donated more than 400ml blood within 3 months before the clinical trial, or who intend to donate blood during the trial; 7. (inquiry) Pregnant or lactating women, or subjects (including male subjects) who have pregnancy plans within two weeks before administration and within three months after the last administration of the test drug, or who do not take one or more effective contraceptive measures, or who have sperm donation or egg donation plans; 8. Subjects who had general physical examination, vital signs and laboratory examination within 7 days before the test, such as blood routine examination, blood biochemistry, coagulation function, urine routine examination, blood HCG / urine pregnancy (female), etc., and ECG within 14 days before the test; 9. Patients with one or more clinically significant tests for HBsAg, hepatitis C virus antibody, anti human immunodeficiency virus antibody or anti Treponema pallidum specific antibody; 10. (inquiry) Patients with clinically significant major diseases or major surgical operations within 3 months before the trial; 11. (inquiry) Subjects whose weekly alcohol consumption is more than 14 units (1 unit = 17.7 ml ethanol, i.e. 1 unit = 357 ml beer with 5% alcohol or 43 ml white wine with 40% alcohol or 147 ml wine with 12% alcohol) in the three months before the test, or subjects who cannot be banned from alcohol during the test; 12. (inquiry) Subjects who smoked more than 5 cigarettes per day on average in the three months before the trial, or who could not stop using any tobacco products during the trial; 13. (inquiry) Those who are unable to eat or have difficulty swallowing, have special requirements for diet and / or fail to follow the unified diet; 14. Patients with a history of asthma or epilepsy; 15. Patients who have used any drugs within 2 weeks before the trial; 16. (inquiry) Objects engaged in high altitude operation, motor vehicle driving and other mechanical operations with risks; 17. (inquiry) Those who can't tolerate venipuncture and / or have history of fainting blood and needle; 18. (inquiry) Subjects with a history of genetic galactose intolerance, lactase deficiency or glucose galactose malabsorption; 19. (inquiry) Subjects who have used soft drugs (such as marijuana) or hard drugs (such as cocaine) within three months before the test or within one year before the test; 20. Those whose alcohol breath test results are greater than 0.0mg/100ml or who are positive in drug abuse screening (morphine, methamphetam
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood drug concentration; | — |
Countries
China
Contacts
Public ContactWeiyong Li
Wuhan Xiangfang clinical pharmacology research center
Outcome results
None listed