KCT0001067尚未招募未知
A randomized, open-label, multiple doses, crossover study to evaluate a pharmacokinetic drug interaction and safety of Amlodipine between free combination of Amlodipine and Candesartan and Amlodipine monotherapy in healthy male volunteers
Chong Kun Dang0 个研究点目标入组 24 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
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
- Male
入选标准
- •Inclusion Criteria:
- •1.Healthy male volunteer is between 20 and 45 years of age(inclusive) at the pre-study(screening).
- •2.Volunteer who has 19kg/m² = BMI(Body Mass Index) = 26kg/m²
- •3.When volunteer in screening, Must include under the items.
- •a.100 mmHg = sitting SBP <140 mmHg
- •b.60 mmHg = sitting DBP < 90 mmHg
- •c.45 bpm = Pulse < 95 bpm
- •4.Those who decided to join the clinical trials by themselves and to comply with the precautions written consent.
排除标准
- •Exclusion Criteria:
- •1.A previous history or present of clinically significant liver, renal, gastro-intestinal, pulmonary, musculoskeletal, endocrine, neuropsychiatric, hemato-oncological, cardiovascular disease.
- •2.Have a gastrointestinal disease history that can affect drug absorption(Crohn's disease, Ulcers, Gastro-esophageal reflux disease, Gastritis, etc.) or surgery (except simple appendectomy or hernia surgery).
- •3.The history of clinically significant hypersensitivity reaction about Investigational drugs and foods.
- •4.The history of drug abuse or drug abuse showed a positive for urine drug test.
- •5.Taking drugs have received any other investigational drug within 90 days prior to the first dosing and metabolizing enzyme inducers or inhibitors such as barbitals within 30 days prior to the first dosing.
- •6.Whole blood donation within 60 days prior to the first dosing or plasma donation within 30 days prior to the first dosing.
- •7.Taking drugs that clinical trials expected to affect within 14days or taking food containing caffeine, grapefruit within 7days before the first dosing.
- •8.A heavy alcohol consumer(alcohol>3cup/day or 3times/week within last 1month)
- •9.A heavy smoker(cigarette>10cigarettes/day)
- •10.The subject has positive results of serum tests(Hepatitis B, C, HIV Test, Syphilis).
- •11.Have the Liver enzyme levels(AST:Aspartate Transaminase, ALT:Alanin Transaminase) or Bilirubin, total results greater than 1.5 times the UNL(Upper Normal Limit).
- •12.Have the result of Creatinine clearance under than 80mL/min(Cockcroft-Gault equation applicable).
- •13.The result of 12-lead ECG in screening test is QTc>450msec.
- •14.An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
研究者
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