None listed
Conditions
Interventions
Drug : Single oral administration of reference products (Rosuvamibe 10/20 mg tablets
fixed dose combination of ezetimibe 10 mg/rosuvastatin 20 mg from old manufacturing line) under fasting conditions and single oral dose of test products (YHP1715 tablet
fixed dose combination of ezetimibe 10 mg/rosuvastatin 20 mg from new manufacturing line) under fasting conditions 2 weeks later. Or taking them vice versa.
Sponsors
Yuhan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under time-concentration curve;Maximum plasma concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under time-concentration curve to infinity;Percentage of the area under curve extrapolated to infinity;Time to maximum plasma concentration | — |
Countries
Korea, Republic of
Contacts
Public ContactJaeWoo Kim
Chungnam National University Hospital
Outcome results
None listed