Hyperlipoidemia
Conditions
Interventions
A:3 periods: Test formulation 20mg, reference formulation 20mg, reference formulation 20mg
B:3 periods: reference formulation 20mg,Test formulation 20mg, reference formulation 20mg
C:3 periods: reference formulation 20mg, reference formulation 20mg,Test formulation 20mg
Sponsors
Beijing Anzhen Hospital of Capital Medical University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Be able to make good communication with researchers. Understand and comply with the various requirements of the present study. Understood and signed the informed consent; (2) Male; (3) 18-40 years old, and age difference is within 10 years; (4) BMI within 19-24 kg/m2, and weight is above 50 kg; (5) Have a good health condition, according to the disease history, physical test, vital signs, ECG and clinical laboratory tests; (6) Negative results in HBsAg, HCV-IgG, HIV1/2-IgM or TPHA-IgM tests; (7) No parenting plan in six months.
Exclusion criteria
Exclusion criteria: 1. Have history of clinically significant allergic reactions, especially drug allergie; 2. Can not communicate with investigators because of neurological and psychiatric disorders or language barriers. 3. Have history of significant disease, which may affect safety and drug ADME; 4. Have disease which may affect drug ADME; 5. Drug abuse history in last 2 years; 6. Cigarette addicted, or smoking 30 days before trial; 7. Alcohol addicted, or 48 hours before dosing; 8. Take any drug in the last 3 months before the study; 9. Take any trial drug in the last 90 days before the study; 10. Blood donation over 200 mL in the last 3 months. Have plan to donate blood or blood components within 1 month after the study; 11. Subjects with hemophobia, or subjects fainting during acupuncture; 12. The subjects researchers consider are not suitable for the clinical trial, or will not complete the trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration; | — |
Countries
China
Contacts
Public ContactLin Yang
Outcome results
None listed