Pharmacokinetics
Conditions
Interventions
1:first period: trial preparation under fasting state
2:first period: reference preparation under fasting state
1:second period: reference preparation under fasting state
2:second period: trial preparation under fasting state
1:third period: trial preparation under fed state
2:third period: reference preparation under fed state
1:fourth period: reference preparation under fed state
2:fourth period: trial preparation under fed state
Sponsors
Institute of Clinical Pharmacy, Central South University
Eligibility
Sex/Gender
Male
Age
21 Years to 27 Years
Inclusion criteria
Inclusion criteria: 1. Gender: male; 2. Age: 18~45 years, with the age difference less than 10 years; 3. Body weight: Body weight not less than 50 kg; Body Mass Index (BMI)=weight (kg)/height (m)2. BMI in this test was within 19~24; 4. Health: Pass general physical examination and blood routine tests, normal liver and kidney functions; 5. Medical History: Subjects with no cardiovascular diseases, no liver or kidney diseases, no diseases in the digestive tract and the mental system; with no drug allergies, no drug dependence, and no postural hypotension; 6. Subjects did not take any other drugs at least two weeks before the trial. 7. Non-smokers and non-drinkers; 8. All subjects are voluntary to take part in the trial and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Abnormalities in general physical examination or laboratory tests; 2. History of cardiovascular, haematological, hepatic, renal, biliary, gastrointestinal, psychological and other acute diseases; drug allergies, drug dependence, and postural hypotension; 3. AIDS and HIV positive; 4. Drug abusers; 5. Subjects in any clinical drug study within two months before the study; 6. Smokers or alcohol consumers; 7. Treatment of other drugs within two weeks before the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration of mesalazine;plasma concentration of N-5-Ac-ASA; | — |
Countries
China
Contacts
Public ContactZhang Bikui
Outcome results
None listed