NCT01005160已完成1 期
A Sequence-randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between CKD-501 and Metformin After Oral Administration in Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- CKD - 501 and metformin Pharmacokinetics evaluation
研究概览
简要总结
The purpose of this study is to evaluate safety, tolerance by comparing availability and the pharmacokinetic drug interaction between the CKD-501 and metformin when administered alone and combination to healthy male volunteers.
详细描述
Volunteers doses three times over the period of CKD-501 0.5mg and metformin 1000mg alone, repeated doses are five days.
In addition, the CKD-501 0.5mg and metformin 1000mg are administered simultaneously be used repeatedly to five days.
Every time before and after each medication safety and drug absorption, distribution, metabolism and excretion rate, and is expected to conduct some tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Between 20 aged and 45 aged in healthy males
- •Weight more than 55kg, IBW 20% within the range
- •FPG 70~125 mg/dL
- •Agreement with written informed consent
排除标准
- •Clinically significant disease(liver, heart, immune system, Respiratory system, Endocrine system, blood tumor disease, Mental illness)or a history that has learned
- •Test drug may affect the absorption of the gastrointestinal disease or a history that has learned
- •Hypersensitivity reactions to drugs or Clinically significant hypersensitivity reactions in the history of party
- •AST, ALT level over to 1.5 times and creatinine clearance less 80mL/min
- •systolic blood pressure less than 100mmHg or 150mmHg, diastolic blood pressure less than 60mmHg or greater than 95mmHg
- •Substance abuse, or a history of drug abuse showed a positive for the party
- •Medication within 2 weeks in the first professional medical, medicine, OTC, vitamins taking
- •Previously participated in other trial within 2 months
- •Medication within 2 months make whole blood donation or medication within 1 month in component blood donation
- •Continued to be drunk or during clinical trials can not be drunk
- •10 cigarettes a day for the last 3 months than the average smoker or during clinical trials can not be smoke
- •Containing grapefruit foods ingested during clinical trials or can not be ingested
- •Containing caffeine foods ingested during 24 hours before admission to hospital of can not be ingested
研究组 & 干预措施
CKD501
Experimental
干预措施: Metformin (Drug)
CKD501
Experimental
干预措施: CKD-501 (Drug)
结局指标
主要结局
CKD - 501 and metformin Pharmacokinetics evaluation
时间窗: 16 days
次要结局
- CKD-501 and metformin safety evaluation(16 days)
研究者
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