Clinical Study to Assess the Pharmacokinetic Interaction Between CKD-501 and Sulfonylurea (Glimepiride) in Healthy Male Subjects: Single-blinded, Randomized, Crossover Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To evaluate the Pharmacokinetic Interaction between CKD-501 and sulfonylurea (Glimepiride) in healthy male subjects
研究概览
简要总结
To assess the pharmacokinetic Interaction between CKD-501 and sulfonylurea (Glimepiride) in healthy male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Participant)
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
- •Healthy male adults aged between 20 and 45 during screening period
- •Weight more than 45kg and within ±20% range of Ideal Boby Weight
- •Agreement with written informed consent
排除标准
- •Subject has signs of symptoms of acute disease within 28 days of starting administration of investigational drug
- •Subject has a history(such as inflammatory gastrointestinal disease, gastric or duodenal ulcer, liver diseases, gastrointestinal surgical histories except for an appendectomy) affects the ADME of drug
- •Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, endocrine system, blood system, digestive system, central nervous system, mental disease or malignancy
- •Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test) within 28 days of starting administration of investigational drug
- •Inadequate laboratory test result
- •AST(SGOT) or ALT(SGPT) > 1.25 x upper limit of normal range
- •Total bilirubin > 1.5 x upper limit of normal range
- •Clinically significant allergic disease(except for mild allergic rhinitis is not needed medication)
- •Subject with known for hypersensitivity reactions to glitazones or sulfonylureas
- •Previously participated in other trial within 60 days
- •Medication with drug-mediated induction/inhibition metabolic enzyme such as barbiturates within 1 month or with may affect the clinical trial within 10 days
- •Subject has taken abnormal meals which affects the ADME of drug
- •Impossible to taking the institutional standard meal
- •Previously donate whole blood within 60 days or component blood within 20 days
- •Continued to be taking caffeine (caffeine > 5 cup/day), drinking(alcohol > 30 g/day) or cannot stop drinking or severe heavy smoker(cigarette > 10 cigarettes per day)during clinical trials
- •An impossible one who participates in clinical trial by investigator's decision including laboratory test result
研究组 & 干预措施
CKD-501 + Glimepiride -> CKD-501 placebo + Glimepiride
This study is randomized, single-blinded, two-period, 2 treatments, crossover design to assess the pharmacokinetics interaction between CKD-501 and sulfonylurea.
干预措施: CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet (Drug)
CKD-501 + Glimepiride -> CKD-501 placebo + Glimepiride
This study is randomized, single-blinded, two-period, 2 treatments, crossover design to assess the pharmacokinetics interaction between CKD-501 and sulfonylurea.
干预措施: CKD-501 placebo tablet, Glimepiride 4 mg tablet (Drug)
CKD-501 placebo + Glimepiride -> CKD-501 + Glimepiride
This study is randomized, single-blinded, two-period, 2 treatments, crossover design to assess the pharmacokinetics interaction between CKD-501 and sulfonylurea.
干预措施: CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet (Drug)
CKD-501 placebo + Glimepiride -> CKD-501 + Glimepiride
This study is randomized, single-blinded, two-period, 2 treatments, crossover design to assess the pharmacokinetics interaction between CKD-501 and sulfonylurea.
干预措施: CKD-501 placebo tablet, Glimepiride 4 mg tablet (Drug)
结局指标
主要结局
To evaluate the Pharmacokinetic Interaction between CKD-501 and sulfonylurea (Glimepiride) in healthy male subjects
时间窗: 0-24 hrs
Blood sampling timepoint : Day 1(0hr), Day 4(0hr), Day 5(0hr),0.5hr, 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 3.5hr, 4hr, 5hr, 6hr, 8hr, 12hr, 24hr(Day 6)- total 16 timepoints per period
次要结局
- To confirm and evaluate the pharmacokinetic characters of main metabolites of CKD-501(0-24 hrs)