KCT0000420招募中未知
Study to Investigate the Influence of OCTN1 and MDR1 Polymorphism on the Pharmacokinetics Properties and the ECG Response of Verapamil in Healthy Volunteers
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 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 Study
入排标准
- 年龄范围
- 20(Year) 至 45(Year)（—）
- 性别
- All
入选标准
- •(1) Male and female Koreans 20 to 45 years of age with body mass index [BMI] between 19 to 26 kg/m2 and weights between 50 to 100 kg.
- •(2) No history of congenital of chronic disease and no specific symptom and sign on medical examination.
- •(3) Specific genotype of MDR1 and OCTN1 (DNA Bank (Establishing a DNA Data Bank for the Pharmacogenomic study in healthy volunteers) (CR No. 4-2008-0318)) can also be used for this).
- •(4) No clnical significant finding in following laboratory test.
- •- Hematology: WBC with differential count, RBC, Hemoglobin, Hematocrit, Platelet
- •- Blood Chemistry: Calcium, Fasting Glucose, BUN, Creatinine, Cholesterol, Albumin, Total Bilirubin, Alkaline phosphatase, AST, ALT, K+, Mg++
- •- Serology: HBsAg, anti-HCV Ab, anti-HIV Ag/Ab (or documented results within 6 months)
- •- Urine analysis: Specific Gravity, pH, Protein, Glucose, Ketone, RBC, Urobilinogen, Bilirubin, Nitrite, WBC, Color, Turbidity, Sediment, Microscopy
- •(5) Female subjects who are of childbearing potential must agree to use effective contraceptive method throughout whole study duration and negative results in urine pregnancy test.
- •(6) The Subject who signed and dated in informed consent document approved by IRB voluntarily after being informed of all pertinent aspects of the research and are willing to follow instructions of study.
排除标准
- •(1) History of significant hypersensitivity of Verapamil or L-Carnitine.
- •(2) Medication which is known to have significant drug interaction within 14 days prior 1st dosing.
- •(3) Clinical evidence of significant respiratory, circulatory, kidney, gastrointestinal, liver, endocrinologic, hematologic, neurologic (including ataxia), psychologic or other chronic disease, intoxication of alcohol or drug, especially heart failure, pitting edema, or dyspnea on exertion.
- •(4) History of convulsion or epilepsy.
- •(5) Unusual dietary habit possibly affecting drug absoption, distribution, metabolism and excretion(eg., grapefruit juice > 1L/day within 7 days prior 1st dosing).
- •(6) History of Gastrointestinal disease (eg., Crohn's disease, Ulcer, etc) or surgical operation (except for simple appendectomy or hernioplasty)possibly affecting oral drug absorption.
- •(7) Excessive intake of caffeint or alcohol, smoker (caffeine: > 5 cups/d, alcohol: >210 g/wk, smoking: > 10 cigarettes/d).
- •(8) Participation in studies (including bioequivalence testing) of other investigational compounds within 30 days prior to the 1st dose of study drug(For the exposure to investigational biologics, 3 months or 3 half-lives (whichever is longer) is required).
- •(9) History of donation whole blood within 60 days or blood components within 30 days prior 1st dosing.
- •(10) A subject have clinically significant results in the screening (history taking, blood pressure, 12-lead ECG, physical examination, blood and urine laboratory test, etc.) test taken within 28 days prior 1st dosing.
- •(11) Systolic blood pressure > 180 or < 100 mmHg, or Distolic blood pressure > 100 or < 60 mmHg, Pulse rate > 100 or < 60 beat/min.
- •(12) Disease history or family history of QT prolongation or arrhythmia.
- •(13) Abnormal ECG finding (including PVC, AV block) or QTcF > 450 msec or QTcB > 480 msec at screening.
- •(14) K+< 3.8mEq/L(=3.8mmol/L) or Mg++< 1.2mEq/L(=0.6mmol/L) at screening, other condition, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
研究者
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