gout
Conditions
Interventions
Single and multiple dose group A:In the fasting state, single and multiple oral doses of 40mg firstly, then single and multiple oral doses of 80mg, finally single oral dose of 120mg
Single and multiple dose group B:In the fasting state, single and multiple oral doses of 80mg firstly, then single oral dose of 120mg, finally singl and multiple oral doses of 40mg
Single and multiple dose group C:In the fasting state, single oral dose of 120mg firstly, then single oral dose of 40mg, finally single and multiple oral doses of 40mg
Effect of feeding group A:Single oral dose of 80mg in the fasting state, then single oral dose of 80mg in the fed state
Effect of feeding group B:Single oral dose of 80mg in the fed state, then single oral dose of 80mg in the fasting state
Sponsors
The first affiliated hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
20 Years to 30 Years
Inclusion criteria
Inclusion criteria: 1) Healthy subjects, the sexual portion is equal; 2) Subject is 18~45 years old and the age difference should less than 10 years in the same batch; 3) BMI in range of 19~25kg/m2 [BMI=weight (kg)/height 2(m2)]; 4) Medical history, physical examination and clinical examination is normal; 5) Without disease history of major organs; 6) Without drug or any other allergies; 7) Non drug abusers; 8) Non alcohol addicts; 9) Withourt using any medicine in the last 2 weeks; 10) Subject is able to communicate with investigator well and comply with requires of study; 11) Informed consent, and signed informed consent.
Exclusion criteria
Exclusion criteria: 1) Participate other clinical trials in the last 3 months; 2) Blood donation in the last 1 month or intend to donate blood in the following 1 month; 3) The general examination and blood pressure, heart rate and respiratory conditions, such as those who are not qualified; 4) Physical examination results judged as clinical significance of abnormal; 5) Laboratory tests found abnormalities in blood, heart, liver and kidney dysfunction; 6) Women in gestation period and lactation period, and menstrual period; 7) 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%; | — |
Countries
China
Contacts
Public ContactJianzhong Shentu
The first affiliated hospital, School of Medicine, Zhejiang University
Outcome results
None listed