Bacteria Infection
Conditions
Interventions
Group A:Taking single 0.5g firstly, then taking single 1g,
Group B:Taking 1g firstly, then taking 2g, finally taking
Group C:Taking 1g firstly, then taking 2g, finally taking
Sponsors
The first affiliated hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Healthy subject2) Subject is 18~45 years old and the age difference should less than 10 years in the same batch; the sexual portion is equal3) BMI in range of 19~25kg/m2 [BMI=weight (kg)/height 2(m2)], including boundary value. Great disparity is not allowed in the weight of subjects in the same batch4) Subject is able to communicate with investigator well and comply with requires of study5) Subject should have a strong understand of the object?nature and eventuality of trial, volunteer for the trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) Specific allergic history (asthma, measles, eczema et.al); Allergic constitution: The persons allergy for investigator product, food, pollen or ingredients of investigator product (analogue); 2) Laboratory test (hematology, urine analysis, blood biochemistry) results 2 weeks before trial judged as clinical significance of abnormal; 3) Any history of severe disease or medical history of cardiovascular system, endocrine system, nervous system, lung, hematology, immunology, pathergasiology and metabolic disturbance; 4) Physical examination and 12-lead electrocardiogram results before trial judged as clinical significance of abnormal; 5) HIV, HBV, HCV, TP-Anti positive; 6) Suffering clinical severe disease or surgery 4 weeks before trial; 7) Participate other clinical trial in the last 3 months; 8) Blood donation in the last 3 month or intend to donate blood in the following 1 month; 9) Used any medicine in the last 2 weeks; 10) Frequently drinking 6 months before trial, averagely get above 14 units alcohol every week (1 unit=beer 360mL or 40% liquor 45mL or wine 150mL); 11) Taking the soft drugs (ecstasy, Ken powder, MaGu et.al) 3 months before trial or hard drugs (cocaine, heroin, meth et.al) 1 year before trial; 12) Averagely take above 1 cigarette a day at the last 3 months; 13) Special requirements for food, refuse to comply with unified diet; 14) Drinking too much tea, coffee or/and drinking with caffeine (averagely 200mL *8 cups a day); 15) Gestation period and lactation period women, menstrual period conflict with trial; 16) Subject can’t complete the trial because of other reasons or unsuitable to participate in the trial considered by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCtn;Cmax;Tmax;t1/2z;CLz;Vz;AUCss;Css_min;Cavg;fluctuation%;Accumulation_index;fration of unchanged drug excreted in urin; | — |
Countries
China
Contacts
Public ContactJianzhong Shen-tu
Outcome results
None listed