KCT0007411已完成未知
An open-label, multiple-dosing, two-arms, one-sequence study to evaluate the safety and pharmacokinetics after co-administration of UIC201601 and UIC201602 in healthy male volunteers
Korea United Pharm0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 45(Year)（—）
- 性别
- Male
入选标准
- •1.Healthy male volunteers aged between 19 - 45 years at screening.
- •2.Subject who weight was = 55 kg and ideal body weight (IBW) was within ±20%
- •[IBW (kg) = (Height(cm) - 100) × 0.9]
- •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.
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 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.
- •3.Subjects with hypersensitivity reactions to drugs like Atorvastatin, HMG-CoA reductase inhibitor.
- •4.Subjects with hypersensitivity reactions to drugs like Omega-3 or fish.
- •5.Uncontrolled genetic disorders such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- •6.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.
- •7.Subject who was HDL-cholesterol < 35 mg/dL.
- •8.Subject who persistent abnormalities in serum potassium concentration (<3.4 mEq/L or >5.5 mEq/L at screening visit).
- •9.Subjects who with a history of muscle disorders or hereditary muscle disorders or family history.
- •10.Subject with a biliary obstruction.
- •11.Subject with active liver disease with persistent and unexplained elevated serum transaminase or AST(GOT), ALT(GPT) > Upper reference rage limit x 3.
- •12.Subject with severe renal dysfunction(creatinine clearance with Cockroft-Gault < 30 mL/min).
- •13.Subject with a history of drug abuse.
- •14.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.
- •15.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 10 days 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).
- •16.Subjects 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.
- •17.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.
- •18.Subject who continuously drink alcohol (more than 21 units/week, 1 unit = 10 g of pure alcohol) or cannot abstain from alcohol from unable to refrain from drinking during within 24 hours prior to hospitalization and until discharge.
- •19.Smokers with an average daily smoking amount exceeding 10 cigarettes per day in recent 3 months.
- •20.Subject who have ingested or can not forcibly consume caffeine-containing foods (coffee, green tea, black tea, carbonated drink, coffee milk, nourishment drink, etc.) until discharge.
- •21.Subjects who were judged by investigator as inappropriate to participate in the clinical trial due to the results of clinical laboratory test results or other reasons
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