Pharmacokinetics and Bioequivalence Study in human
Conditions
Interventions
1:Phase I: JMP-Risperidone produced Risperdal Tab 4 mg
2:Phase I: Janssen-Cilag SpA-V.C.Janssen produced Risperdal Tab 4 mg
1:Phase II: Janssen-Cilag SpA-V.C.Janssen produced Risperdal Tab 4 mg
2:Phase II: JMP-Risperidone produced Risperdal Tab 4 mg
Sponsors
Institute of Clinical Pharmacy , Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. CYP2D6 extensive metabolizer; 2. Male and female aged 18 to 45 years, with the age difference less than 10 years; 3. BMI 19 to 26; 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 informed consent form.
Exclusion criteria
Exclusion criteria: 1. CYP2D6 poor metabolizer; 2. Abnormalities in general physical examination or laboratory tests; 3. History of cardiovascular, haematological, hepatic, renal, biliary, gastrointestinal, psychological other acute diseases; drug allergies, drug dependence, and postural hypotension; 4. AIDS and HIV positive; 5. Drug abusers; 6. Subjects in any clinical drug study within months before the study; 7. Smokers or alcohol consumers; 8. Treatment of other drugs within two weeks before the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration of Risperidone; | — |
Countries
China
Contacts
Public ContactZhang Bikui
Institute of Clinical Pharmacy, Central South University
Outcome results
None listed