KCT0001660招募中未知
A phase I study to evaluate the pharmacokinetic interactions and safety between Amlodipine/Valsartan combination tablet and Rosuvastatin in healthy adult volunteers
Kyung Dong Pharmaceutical0 个研究点目标入组 57 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 57
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 o Limit（—）
- 性别
- Male
入选标准
- •1) Healthy male subject‘s age = 19 years at screening
- •2) Body weight of = 50 kg and within ± 20% of ideal body weight
- •? IBW (kg) = height (cm) - 100} * 0.9
- •3) No abnormal symptom or sign, based on medical history and physical examination, with no congenital or chronic disease
- •4) Subject that is considered eligible for participating in the study by an investigator, based on clinical laboratory test (serology, hematology, clinical chemistry, urinalysis, etc.) and ECG, performed within 3 weeks prior to administration of study drug
- •5) Subjects who understand a detailed explanation of the study protocol, voluntarily decide to participate and follow the study instructions, and sign Informed Consent
排除标准
- •1) Medical History of clinically significant hypersensitivity to study drug (major ingredient or any other ingredient), any other drug or additives
- •2) Medical history that may affect the absorption, distribution, metabolism or excretion (hepatobiliary, renal, cardiovascular, endocrine (e.g., hypothyroidism), respiratory, gastrointestinal, hemato-oncology, central nervous system, psychiatric and musculoskeletal system)
- •3) an history (or family history) of muscle disease hereditarily
- •4) Hypotension (systolic = 115 mmHg or diastolic = 65 mmHg) or hypertension (systolic = 150 mmHg or diastolic = 100 mmHg), measured at screening
- •5) Active liver disease, or the levels of ALT, AST or total bilirubin > 1.5 x the upper limit of normal
- •6) Creatinine clearance < 80 mL/min (calculated by Cockcroft-Gault formula using serum creatinine)
- •7) History of gastrointestinal disease (e.g., Crohn’s disease, active peptic ulcer) or gastrointestinal surgery that may affect the absorption of the study drug (excluding simple appendectomy or herniorrhaphy)
- •8) History of major injury, surgical operation, or suspected symptom of acute illness (severe infection, trauma, diarrhea or vomiting, etc.) within 4 weeks prior to the first administration of study drug
- •9) History of excessive alcohol abuse (>21 units/week, 1 unit=10g=12.5mL of pure alcohol), or subjects who cannot abstain from drinking for at least 3 days prior to the start of this study and during the study period, or excessive smoking (>10 cigarettes/day)
- •10) Use of any prescribed drugs or herbal remedies within 2 weeks, or use of any over-the-counter medication within 1 week prior to the first administration of study drug, and this will affect this study or the safety of the subjects in the opinion of the investigator
- •11) Participation in any other study within 3 months prior to the first administration of study drug (The completion date of previous study is the day of the last administration of study drug)
- •12) Donation of whole blood within 2 months prior to the first administration of study drug, or donation of any blood component within 1 month prior to the first administration of study drug
- •13) Abnormal diet that may affect absorption, distribution, metabolism and excretion of drugs (*e.g., Grapefruit juice = 1L /day within 7 days prior to administration of study drug)
- •14) Positive serologic tests (HBsAg, HCV Ab, HIV Ag/Ab, VDRL)
- •15) Subject that is not eligible to participate at the discretion of study investigator
研究者
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