Pharmacokinetics and Bioequivalence Study in human
Conditions
Interventions
fasting group 1:phase I: T
fasting group 2:phase I: R
feeding group 1:phase I: T
feeding group 2:phase I: R
Sponsors
Xiangya Boai Rehabilitation Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 55 years, both males and females, including boundary values; 2. Body weight of male >= 50 kg, body weight of female >=45 kg, and Body Mass Index (BMI) ranged within 19 ~26 kg/m2 including boundary values; 3. All subjects signed the written informed consent.
Exclusion criteria
Exclusion criteria: 1) History or at present suffering from any serious clinical disease, such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic disorders; 2) History or at present suffering from Parkinson's disease, Parkinson's syndrome, tremor, restless legs syndrome, and other motor disorders; 3) Subjects with chronic or active gastrointestinal diseases such as esophageal disease, gastritis, gastric ulcer, diverticulitis, enteritis, active gastrointestinal bleeding, gastrointestinal perforation or gastrointestinal surgery within three years; 4) Subjects with postural hypotension or need to take antihypertensive drugs; 5) Subjects who are professional athlete or engaged in sports; 6) Subjects who need drive, operate machinery and work high above the ground during the test period or one week after the trail; 7) Subjects who have a history of allergy to drugs (such as Trimetazidine or any other substance in this preparation), food or other substances; 8) Subjects who have had an surgical procedure during 4 weeks before the study or planned surgery during the study; 9) Treatment of any medicine (including Chinese herbal medicine and health products) within 14 days before the study; 10) Treatment of any drug that inhibited or induced the metabolism of the liver (such as the inducer-barbiturate, carbamazepine, phenytoin, glucocorticoid, omeprazole, inhibitor -SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazole, sedative hypnotics, and verapami, fluoroquinolones, antihistamine), any nitrate esters, alpha blocker drugs, PDE5 inhibitors and endothelin receptor antagonists 30 days before the study; 11) Subjects who vaccinated within 30 days before the study, or planned to vaccinate during the study or 3 months after the study; 12) Subjects who took part in any other clinical trial within 3 months before the study; 13) Subjects who donated blood or had the frequency of blood loss of > 200 mL within 3 months before the study; 14) Subjects who are unable to take 1 or more contraceptive measures before the 2 weeks of study, during the trial and 3 months after the trial, and who are pregnancy, sperm donation and egg donation planners; 15) Subjects who have special requirements for diet, and can not comply with a unified diet; 16) Subjects drink excessive amounts of tea, coffee and / or beverages with caffeine or xanthine (8 cups or more, 1 cups =250 mL) per day, or do not agree to stop drinking during the study; 17) Smokers or those who smoke more than 5 cigarettes per day 3 months before the study, or do not agree to stop smokeing during the study; 18) Drinkers or those who drink frequently 6 months before the study, that is, drinking more than 14 units of alcohol per week (1 unit =360 mL of beer or 45 mL of alcohol with 40% of alcohol or 150 mL of wine), or do not agree to stop drinking during the study; 19) Drug abusers or those who used soft drugs (such as cannabis) 3 months before the start of study or those who took hard drugs (such as cocaine, phencyclidine, etc.) 1 years before the start of study. 20) Subject with vasovagal syncope, poor venous and vascular conditions or difficult puncture; 21) Subjects with poor compliance or other reasons that prevent the volunteers from finishing the study, or the researchers do not agree to recruit him or her; 22) Subject with the endogenous creatinine clearance rate (Ccr) < 80 ml/min (calc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC; | — |
Secondary
| Measure | Time frame |
|---|---|
| tmax;t1/2; | — |
Countries
China
Contacts
Public ContactZhang Bikui
Outcome results
None listed