Bioequivalence
Conditions
Interventions
T---R:T---R
R---T:R---T
Sponsors
Medical Ethics Committee of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Chinese male or female aged 18 years and more; 2) weight: male subjects should not be less than 50 kg, female subjects should not be less than 45 kg, body mass index (BMI = weight (kg)/height^2 (?) ] within the scope of the 19 ~ 26 kg/? (including boundary value); 3) screening has no clinical significance of vital signs, physical examination, laboratory examination and electrocardiogram examination results abnormal; 4) the subjects should be taking medication during his research to within 3 months after drug withdrawal to physical precautions, to avoid pregnancy; 5) Did not taking any other drugs in past two weeks; 7) no drugs or other food allergies, no history of mental illness and history of drug dependence; 8) volunteered for the experiment and sign a consent form; 9) to observe the treatment procedure and blood samples.
Exclusion criteria
Exclusion criteria: 1) during pregnancy, lactation, menstrual period (according to the law of menstruation in subjects that trial period 0 ~ 9 days menstruating) of women, experiment during or after the end of three months have fertility planning subjects; 2) physical examination does not meet the subject's health standards; Awake heart rate 20 times per minute, or forehead temperature >37.5 degree C; 3) of the central nervous system, cardiovascular system, kidney, liver, gastrointestinal, respiratory (asthma, cough, etc.), blood system, metabolism, and clear the history of musculoskeletal system, or to interfere with the test results of any disease or other physiological condition; 4) has a tendency to hemorrhage (such as the recent trauma, recent surgery, blood coagulation dysfunction, activity, or recent intestinal bleeding), a history of intracranial hemorrhage, history of hemophilia, von willebrand disease history, or other can change or increase the bleeding tendency of disease (peptic ulcer, hemorrhoids, allergic purpura, lupus erythematosus (sle), etc.); 5) detection of the abnormality of the thrombus; 6) ? degree atrioventricular block, sinus bradycardia (resting heart rate 100 times/min); 7) it is known that this product and its auxiliary materials (mannitol, calcium phosphate, carboxymethyl starch sodium, hydroxypropyl cellulose, magnesium stearate) are known to be allergic; 8) has a history of drug abuse and illicit drugs, urine drug test (benzodiazepine azole sedative hypnotics, methadone, opioid analgesics, cocaine, amphetamines, local anaesthetic hallucinogenic drugs); 9) in the past one year before the experiment, there was obvious smoking and drinking habit (>and 5 cigarettes per day; Drinking more than 14 units of alcohol per week (a bottle of 350mL of beer, 120mL of liquor or 30mL of liquor); 10) in the past three months before the trial, participants in other drugs or instruments or participating in other clinical trials; 11) the history of blood donation in the first month of the trial, or the intention to donate blood or blood components during the study period; 12) nearly 2 weeks had to take a variety of drugs (including Chinese herbal medicine), the experiment used within 30 days before any CYP3A drug or drug induced liver enzyme inhibition (see the appendix table 1) and food or anticoagulant drugs; 13) does not guarantee from 48 hours before taking the medicine to the front of the last blood banned smoking and serve grapefruit juice or any food and drinks containing alcohol and xanthine person (including chocolate, tea, coffee, coke, etc.); 14) the researchers believe that the subjects may not be able to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC 0-t;AUC 0-8;Cmax;Tmax;T1/2;Vital signs;Physical examination;ECG;Blood biochemistry;Coagulation;Urine routine;stool routine;thrombelastogram;blood routine;blood routine;Adverse events; | — |
Countries
China
Contacts
Public ContactRui Wang ,Yun Cai
Chinese PLA General Hospital
Outcome results
None listed