None listed
Conditions
Interventions
Drug : 1. Reference drug 1: Pletaal SR Cap. 100mg 2 capsules (Cilostazol 200 mg)
2. Reference drug 2: Crestor Tab. 20mg 1 tablet (Rosuvastatin 20 mg)
3. Test drug: UI022 1 tablet (Cilostazol 200 mg +
Sponsors
Korea United Pharm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers aged between 19 - 45 years at screening. 2. Subject who weight was = 55 kg and ideal body weight (IBW) was within ±20%. 3. Subject who don’t have congenital or chronic disease and any pathologic sign or symptom from medical check-up. 4. Subject who be within normal range by clinical laboratory results such as hematology test, blood chemistry test, urine test, etc. 5.Subject who be informed of and completely understood this clinical trial and signed the written informed consent for voluntary participation. 6. For women, non-pregnancy confirmed by medical examination
Exclusion criteria
Exclusion criteria: 1. Subject who have a clinically significant past or present medical history of hepato-biliary, renal, respiratory, hematologic/neoplastic, urologic, psychiatric, cardiovascular (hypertension, angina, heart failure, myocardial infarction, etc.)and endocrine diseases(diabetes, hyperlipidemia). 2. Subject with bleeding (e.g. haemophilia, capillary fragility, intracranial bleeding, upper gastrointestinal bleeding, urinary tract bleeding, haemoptysis, supra-autologous bleeding, etc.) or known predisposition to bleeding (e.g. Active peptic ulcer, haemorrhagic stroke within the last 6 months, surgery within 3 months, proliferative diabetic retinopathy, uncontrolled hypertension). 3. Subject with atrial or ventricular potentials, atrial fibrillation or flutter, ventricular tachycardia, ventricular fibrillation, multifocal ventricular ectopic rhythm, and prolonged QT interval. 4. Subject with a history of gastrointestinal disease (e.g. Crone’s disease, ulceration, acute or chronic pancreatitis, etc) or surgery (except simple appendectomy or repair of a hernia), which can influence the absorption of the study drug. 5. Subject with history of hypersensitivity to cilostazol or other antiplatelet agents. 6. Subject with history of hypersensitivity to rosuvastatin, atorvastatin, simvastatin or other HMG-CoA reductase inhibitor. 7. Uncontrolled genetic disorders such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. 8. Subject with abnormal result of PT and aPTT (PT [INR] 0.8~1.2, aPTT [sec] 25.1~36.5). 9.Subject who was systolic blood pressure (SBP) = 140 mmHg mmHg or 5.5 mEq/L. 12. Subjects who with a history of muscle disorders or hereditary muscle disorders or family history. 13. Subject with a biliary obstruction. 14. Subject with active liver disease with persistent and unexplained elevated serum transaminase (AST and ALT) or total bilirubin > Upper reference rage limit x 2. 15. Subject who was creatine phosphokinase > Upper reference rage limit x 2. 16. Subject with moderate renal dysfunction(creatinine clearance with Cockroft-Gault < 60 mL/min). 17. Subject who have a history of drug abuse or who were positive for the abused drug. 18. Subject who took barbiturates or an inducer or inhibitor of drug metabolite enzymes or have consumed excessive alcohol within 1 month before the first study drug administration. 19. Subject who used ethical-the-counter drugs or herbal medicine within 2 weeks prior to the scheduled 1st study drug administration and who used over-the-counter drugs or vitamin within 1 week prior to the scheduled 1st study drug administration (But, subject whose other conditions are judged by investigators as appropriate for this clinical trial could participate in this study). 20. Subject who has participated in any other clinical trial either for investigational or marketed drugs within 3 months prior to the scheduled 1st study drug administration. 21. Subject who donated whole blood within 2 months or blood components within 1 month before the first administration, or who received blood transfusion within 1 month before the first administration. 22. For women, pregnant/breastfeeding or who do not agree to maintain use of a medically accepted dual method of contra
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration ;Maximal plasma concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve from zero to infinity;Time for the maximal plasma concentration;Terminal elimination half-life;Apparent Clearance | — |
Countries
Korea, Republic of
Contacts
Public ContactKim Jae hoon
Chungnam National University Hospital
Outcome results
None listed