Bioequivalence
Conditions
Interventions
R-T:R(Reference)-T(Test)
T-R:T(Test)-R(Reference)
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Healthy male and female volunteers; 2) Aged >18 years old; 3) Body Weight: BMI(calculated as body weight (kg)/height (m^2)) between 19.0 and 26.0, female body weight = 45 kg, male body weight = 50 kg; 4) Volunteers are in good health condition (no significant clinical syndromes, no clinically significant abnormal laboratory measurements); 5) Subject participate in this trial volunteerly and sigh an informed consent form in comply with the GCP.
Exclusion criteria
Exclusion criteria: 1) The subjects have clinically significant abnormal laboratory measurements, or other clinically significant diseases, including but not limited to, diseases of kidney, liver, gastrointestinal tract, cardiovascular system and nervous system; 2) The subjects have confirmed medical history of suffering from central nervous system, cardiovascular system, kidney, liver, digestive tract, respiratory tract, blood, metabolic system and skeleton muscle; 3) The subjects have medical history of HBV, HCV, HIV and TP infections. 4) The subjects have medical history of ulcer of digestive tract and/or bleeding of gastrointestinal tract; 5) The subjects have abnormal systolic pressure(37.4?) abnormalities during screening; 6) The subjects are known to be allergic to flurbiprofen (or any other NSAIDS) or food 7) Pregnant and lactating female; 8) The subjects have hobbies of smoking (>5 cigarettes/day or equivalent amount of nicotine), alcohol abuse (>14 alcohol units per week, 1 alcohol unit = 10 mL or 8 g pure alcohol, 25 mL of 40% spirit, 330 mL of 5% beer, 175 mL of 12% wine contains 1.0, 1.5 and 2.0 alcohol unit, respectively) and medicine/drug abuse; 9) The subjects intends to breed (including male subjects) within 3 months upon completion of the study. 10) Blood donating within 3 months before screening; 11) The subjects took any medicines (including herbs and dietary supplements) within 2 weeks before the screening; 12) The Subjects smoked or consumed any food and drink containing alcohol, xanthine, or grape fruit juice (including but not limited to chocolate, coffee or cola); 13) Any abnormal result is found in urine drug test 14) BAC (blood alcohol concentration (BAC)=20 mg/100 mL); 15) Any other situation that the investigator think may affect the safety of subjects and judgment of results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-8;AUC0-t;Cmax; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;T1/2; | — |
Countries
China
Contacts
Public ContactJin Wang, Yun Cai
Chinese PLA General Hospital
Outcome results
None listed