None listed
Conditions
Interventions
fasted group:Phase I: test preparation, reference preparation
Phase II: reference preparation, test preparation.
fed group:Phase I: test preparation, reference preparation
Sponsors
Shenzhen Second People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study: 1) Subjects who are willing to participate in this trial and sign the informed consent before the trial. 2) Healthy Chinese male and female subjects, between the ages of 18 and 45 years, inclusive. 3) BMI of 19.0 to 26.0 kg/m2, inclusive; and a total body weight >= 50 kg for males and >= 45 kg for females.(BMI=weight/ height2) 4) The medical history, physical examination, vital signs, laboratory examination, and ECG are all defined as no abnormalities or no clinical significance.(Based on the judgment of the clinician) 5) Not taking any medications within 2 weeks prior to dosing. 6) Subjects who are willing to use effective non-drug methods of contraception for the duration of the study and for 6 months after the last dose of investigational medication. 7) Female subjects with negative blood HCG and urine HCG tests. 8) Subjects who understand the trial content, process and possible adverse reactions before signing the informed consent. 9) Subjects who can communicate well with the investigator and understand and comply with the requirements of the trial.
Exclusion criteria
Exclusion criteria: Subjects with any of the following characteristics/conditions will not be included in the study: 1) Subjects with allergic constitution, allergic disease or are known allergy to investigational medication. 2) Past or current suffering from circulatory system, respiratory system, digestive system (gastrointestinal tract, liver), blood system, nervous system, immune system, urinary system (kidney), endocrine system, mental system (such as Parkinson, epilepsy, etc.) , or other diseases that may significantly affect drug absorption, distribution, metabolism and excretion, history of surgery, or bleeding diseases (such as gastrointestinal ulcer, hemorrhagic stroke, etc.) . 3) Subjects with a positive urine drug screen, or history of drug abuse within the past 3 months. 4) Female subjects during pregnancy or lactation; female or male subjects (or their partners) of childbearing age who are unable to perform contraception as required; female subjects or spouses of male subjects who have a birth plan within half a year after the trial. 5) Subjects who regularly take drugs or drink (drink more than 21 units of alcohol per week, 1 unit = 360mL beer or 45mL white wine or 150mL wine), or cannot stop alcohol. 6) Smokers or those who cannot stop using any tobacco products during the trial. 7) Subjects who donated more than 400 mL of blood within 90 days before the test, who donated plasma 14 days before the trial, or who lost blood more than 200 mL for other reasons. 8) Subjects who have been vaccinated within 4 weeks before first taking investigational medications, use any prescription medication, herbal supplements, and / or use any over-the-counter (OTC), vitamins, nutritional supplements, drink or food containing grapefruit within 2 weeks before first taking investigational medications. 9) Subjects who participated in any clinical trial in the past 3 months. 10) Subjects who underwent surgery within 4 weeks before the trial, or plan to undergo surgery within 2 weeks after the trial. 11) Any abnormal infection screening (HBsAgAnti-HCVAnti-HIVAnti-TP). 12) Patients with a previous history of epilepsy and angle-closure glaucoma; patients with a history of myopathy or myolysis. 13) Subjects with a history of schizophrenia or depression, suicide attempts or ideas. 14) Subjects who have used drugs known to damage certain organs within three months before the trial, or those who have taken monoammonium oxidase inhibitors such as phenylethylhydrazine, bromfaromine, toloxadone, isoxazine (boring cola), phencycline, moclobemide; or tricyclic antidepressants such as selegiline Lin, doxepin, clomipramine; or drugs that prolong clotting time such as warfarinor have received oral rasirone treatment. 15) Subjects with fever within three days before the trial. 16) Pulse 100 beats/min. 17) Systolic blood pressure = 140mmHg, diastolic blood pressure = 90mmHg. 18) Subjects who cannot diet uniformly during the study period; or refuse to discontinue any drinks or foods containing methylxanthine, such as caffeine (coffee, tea, cola, chocolate); or subjects who are assigned to the high-fat meal group cannot use it at the prescribed time. 19) Investigators consider it unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t, AUC0-inf, Cmax?Tmax, Vd/F, Kel, t1/2, CL/F; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation index; | — |
Countries
China
Contacts
Public ContactJianlong Wu
Shenzhen Second People's Hospital
Outcome results
None listed