Pharmacokinetics and Bioequivalence Study in Human
Conditions
Interventions
Group 1:Phase 1: simvastatin tablets 20 mg (Europharm Lab Co Ltd., Hong Kong)
Phase 2: simvastatin tablets 20 mg (Merck Sharp & Dohme Limited)
Group 2:Phase 1: simvastatin tablets 20 mg (Merck Sharp & Dohme Limited)
Phase 2: simvastatin tablets 20 mg (Europharm Lab Co Ltd., Hong Kong)
Sponsors
Institute of Clinical Pharmacy, Central South University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18~40 years male and femal with the age difference less than 10 years; 2. Body weight: Body Mass Index (BMI)=weight (kg)/height (m); BMI in this test was within 19~24; 3. Health: Pass general physical examination and blood routine tests, normal liver and kidney functions; 4. 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; 5. Subjects did not take any other drugs at least two weeks before the trial; 6. Non-smokers and non-drinkers; 7. 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 concentrations of simvastatin and simvastatin acid; | — |
Countries
China
Contacts
Public ContactZhang Bikui
Institute of Clinical Pharmacy, Central South University
Outcome results
None listed