KCT0000413招募中未知
A randomized, open-label, single dose, 2-treatment, 2-period, 2-way crossover stydu to assess the pharmacokinetic characteristics of YH14659, a fixed dose combination compared with coadministration of separate constituents under fasted condictions in healthy male subjects
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- Yuhan
- 入组人数
- 60
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
- 20(Year) 至 55(Year)（—）
- 性别
- Male
入选标准
- •1. Healthy male subjects between the ages of 20 and 55 years at screening
- •2. Subjects with a body weight within ± 20% of their ideal weight and over 55kg
- •3. Subjects must be in generally good health as determined by pre-study medical history and physical examination, with no congenital or chronic diseases.
- •4. Subjects must be in generally good health as determined by laboratory tests including blood hematology, biochemistry, blood clotting test, urinalysis, and serologic tests;
- •5. Subjects must be able to read, understand, and willing to decide to participate in the study, follow the study directions and provide written informed consent.
排除标准
- •1. Presence or history of hypersensitivity to clopidogrel, aspirin, or other anti-thrombotic drugs
- •2. Subjects with systolic blood pressure = 100 mmHg or diastolic blood pressure = 50 mmHg, or systolic blood pressure = 145 mmHg or diastolic blood pressure = 95 mmHg, with pulse rate < 45 bpm or > 100 bpm
- •3. Subjects with AST or ALT count, the upper limit of reference range in excess of 1.25 times, or total bilirubin, the upper limit of reference range in excess of 1. 5 times, or PT, aPTT, BT exceeded the reference range
- •4. Subjects with platelet count < 150,000/microL or > 350,000/micro/L
- •5. Subjects with active bleeding (hemophilia, capillary fragility, intracranial hemorrhage, upper gastrointestinal bleeding, gross hematuria, hemoptysis, vitreous hemorrhage, and so on) or subjects showing bleeding tendency (active peptic ulcer, hemorrhagic stroke within 6 months, surgical interventions within 3 months, proliferative diabetic retinopathy, refractory hypertension, and so on)
- •6. Presence or history of cardiovascular, pulmonary, renal, endocrine, hematologic (including bleeding tendency), gastrointestinal, central nervous system, psychiatric, or malignant disease
- •7. Subjects with atrial and ventricular displacement, atrial fibrillation or flutter, ventricular tachycardia and ventricular fibrillation, or multifocal ventricular ectopic beats, QT interval prolongation
- •8. A history of gastrointestinal disease (e.g., Crohn’s disease, ulceration) or resection operation (excluding simple appendectomy or herniorrhaphy)
- •9. Presence or history of peptic ulcer or gastrointestinal hemorrhage within 2 months prior to scheduled study drug administration
- •10. History of alcohol abuse or excessive smoking, or subjects who are not willing to abstain from drinking or smoking for the duration of study
- •11. Use of any other investigational drugs within 3 months prior to scheduled study drug administration
- •12. Donation of whole blood within 2 months or any blood products within 1 month, prior to scheduled study drug administration
- •13. Use of drugs which are P450 inducers or inhibitors (e.g. Phenobarbital) within 1 month prior to scheduled study drug administration
- •14. Use of any prescription drugs or herbal remedies within 2 weeks, or use of any over-the-counter medication within 1 week prior to scheduled study drug administration
- •15. Current or previous abuse of drugs or alcohol
研究者
相似试验
已完成
不适用
Pharmacokinetics of cilostazol controlled- and immediate-release (Pletal) tabletsKCT0002340Korea United Pharm30
招募中
不适用
Pharmacokinetic study for fixed-dose combination of clopidogrel and aspirin in healthy volunteersDiseases of the circulatory systemKCT0000412Ildong pharmaceutical60
已完成
不适用
Study to investigate the effect of atorvastatin on the pharmacokinetic properties of telmisartan/s-amlodipine after oral administration in healthy volunteersDiseases of the circulatory systemKCT0000811Chong Kun Dang24
已完成
不适用
Study to investigate the effect of telmisartan/s-amlodipine on the pharmacokinetic properties of atorvastatin after oral administration in healthy volunteersDiseases of the circulatory systemKCT0000810Chong Kun Dang24
招募中
不适用
A Randomized, Open-label, Single-Dose, 2-Treatment, 2-Way, 2-Period Crossover Study to Assess the Safety and the Pharmacokinetic Characteristics of Lodivikar tab. 5/40 mg in Healthy Adult Male SubjectsDiseases of the circulatory systemKCT0001252Hanlim Pharmaceutical32