Bioequivalence study of Rosuvamibe (rosuvastatin 20 mg/ezetimibe 10 mg fixed dose combination) tablets
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0003310
- Lead Sponsor
- Yuhan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
1. Healthy males.
2. No congenital disorders or chronic diseases. No morbid conditions.
3. No clinically relevant abnormalities identified by laboratory tests.
4. Body mass index of 18.0 to 30.0 kg/m2.
5. No history of whole blood donations within 2 months, or apheresis within 2 weeks prior to the screen.
6. No history of gastrointestinal surgery affecting the absoprtion of oral medicins.
7. No history of psychiatric illnesses within 5 years prior to the screen.
8. A voluntarily signed informed consent indicating that the subject has been informed of all pertinent aspects of the trial.
9. Subjects who are willing and able to comply with scheduled visits, treatments plan, laboratory tests, and restrictions.
10. Females without evidences of pregnancy.
1. Use of cytochrome P450 inducers or inhibitors within 30 days prior to the screen.
2. Use of medicines affecting the result of the trial within 10 days prior to the screen.
3. Subjects considered ineligible by investigators.
4. Enrolled in any clinical study within 3 months prior to the first dose of investigational products.
5. Intolerable to venipunctures.
6. Regular alcohol comsumption exceeding 21 units/week (14 units/week for females) within 6 months of screening.
7. Intolerance or allergic reaction to any ingredient of study drugs.
8. Active liver diseases or sustained increase of serum aminotransferases.
9. Muscle diseases.
10. Concurrent use of cyclosporine.
11. Creatinine clearance < 30 mL/min.
12. Lactating women.
13. Hereditary disorders such as galatose intolerance, Lapp lactose deficiency, glucose-galatose malabsorption, and so on.
14. Unable to use appropriate contraception from the first dose of investigational drugs to 14 days after the last dose of study drugs.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area under time-concentration curve;Maximum plasma concentration
- Secondary Outcome Measures
Name Time Method Area under time-concentration curve to infinity;Percentage of the area under curve extrapolated to infinity;Time to maximum plasma concentration