KCT0008886已完成Unknown
An open-label, single-dose, six-sequence, three-treatment, three-period study to compare the safety, food effect and pharmacokinetic characteristics of UI022(fixed-dose combination of UIC201603 and UIC201604) with co-administration of the two separate drugs in healthy volunteers
Korea United Pharm0 个研究点目标入组 48 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 45(Year)（—）
- 性别
- All
入选标准
- •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
排除标准
- •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 < 90 mmHg, diastolic blood pressure (DBP) = 95 mmHg or < 60 mmHg or pulse rate (PR) = 100 /min.
- •10. Subject who was HDL-cholesterol < 35 mg/dL.
- •11. Subject who was serum potassium concentration < 3.4 mEq/L 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
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