KCT0002340已完成未知
A Randomized, Open-label, Single dose, 2-Treatment, 2-Period, 2-Way Crossover Study to Assess the Pharmacokinetic Characteristics of a Cilostazol Controlled-Release Tablet Compared with a Cilostazol Immediate-Release Tablet under Fasted Conditions in Healthy Male Subjects
Korea United Pharm0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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 55(Year)（—）
- 性别
- Male
入选标准
- •1)A healthy male subject ages 19 to 55 years (both inclusive)
- •2)A subject with body weight = 55 kg and in the range of ideal body weight (IBW) ± 20% (refer to Appendix7)
- •3)A subjects with findings within the range of clinical acceptability in medical history and physical examination
- •4)A subject with laboratory results within the laboratory reference ranges for the relevant laboratory tests (unless the investigator considered the deviation to be irrelevant for the purpose of the study)
- •5)A subject who is informed of the investigational nature of this study, and voluntarily agrees to participate in this study and signs informed consent
排除标准
- •1)A subject with drug hypersensitivity to cilostazol or other antiplatelet agents
- •2)A subject whose systolic blood pressure (SBP) = 100 mmHg or = 145 mmHg, diastolic blood pressure (DBP) = 50 mmHg or = 95 mmHg or pulse rate (PR) = 100 /min
- •3)A subject whose PT or aPTT test result was out of reference range (Reference range of PT and aPTT test were 11-15 sec, 22.4-40.4 sec, respectively)
- •4)A subject with clinical evidence or history of bleeding (hemophilia, Capillary fragility, intracranial hemorrhage, upper gastrointestinal bleeding, urinary tract bleeding, hemoptysis, vitreous bleeding, etc.) or bleeding tendency (active peptic ulcer, hemorrhagic stroke within 6 months, surgery within 3 months, proliferative diabetic retinopathy, uncontrolled hypertension, etc.)
- •5)A subject with clinical evidence or history of cardiovascular (congestive heart failure, coronary artery stenosis, etc.), respiratory, renal (severe renal failure, etc.), endocrine (diabetes or impaired glucose tolerance), hematologic (bleeding tendency), gastrointestinal, central nervous system, psychiatric, oncologic or hepatic (moderate or severe hepatic failure, etc.) disease
- •6)A subject with clinical evidence or history of atrial and ventricular displacement, atrial fibrillation, atrial flutter, ventricular tachycardia, ventricular fibrillation, multifocal ventricular ectopic beats or QT interval prolongation
- •7) A subject with history of gastrointestinal disease (Crohn’s disease, ulcer, etc.) or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug
- •8)A subject with clinical evidence or history of peptic ulcer or gastrointestinal bleeding within 2 months prior to the scheduled 1st investigational product administration
- •9)A subject who consumes more than 21 units of alcohol per week (1unit=10g=12.5mL) or smokes more than 20 cigarettes per day, or unable to stop drinking or smoking throughout the study period
- •10)A subject who has participated in any other clinical trial either for investigational or marketed drugs within 3 months prior to the scheduled 1st investigational product administration
- •11)A subject who has donated whole blood within 2 months or any blood products within 1 month prior to the scheduled 1st investigational product administration
- •12)A subject who has taken any medication which can induce or inhibit drug metabolizing enzymes within 1 month prior to the scheduled 1st investigational product administration (e.g. barbiturate)
- •13)A subject who has taken any prescribed medication such as anticoagulants (warfarin, etc.), antiplatelet agents (aspirin, ticlopidine, etc.), thrombolytic agents (urokinase. alteplase, etc.) prostaglandin E1 (alprostadil, limaprost alfadex, etc.) or herbal compounds within 2 weeks prior to the scheduled 1st investigational product administration. In addition, a subject who has taken any over-the-counter drug within 1 week prior to the scheduled 1st investigational product administration. (However, investigators can judge the subject, who has taken the medications during those periods above, eligible for the trial if all other conditions are satisfied.)
- •14)A subject with psychiatric disorder or drug or alcohol abuse history
- •15)The investigator judges the subject is not eligible for the study after reviewing clinical laboratory results or other reasons
- •16)A subject who takes grape juice, grapefruit juice or grapefruit-containing products within 1 week prior to th
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