NCT02614352Unknown1 期
Investigate a Pharmacokinetic Characteristics and the Safety of AG1502 in Healthy Male Subjects
Ahn-Gook Pharmaceuticals Co.,Ltd0 个研究点目标入组 60 人开始时间: 2015年11月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 主要终点
- Cmax (candesartan cilexetil)
研究概览
简要总结
Primary object : Evaluate pharmacokinetic property AG1502 and Candesartan 32mg and Atorvastatin 40mg 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
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult healthy males 19 to 45 years at screening.
- •BMI 18-29 kg/m2
排除标准
- •History of cardiovascular, respiratory, hepatic, renal, neuropsychiatric, endocrine, hematologic disease
- •Hypersensitivity reactions to drugs or significant hypersensitivity reactions in the history of Candesartan and Atorvastatin
- •Hypotension (DBP ≤ 100 mmHg or SBP ≤ 95mmHg) and hypertension (SBP ≥ 150 mmHg or DBP ≥ 95 mmHg)
- •Gastrointestinal disease affected the absorption of medications
- •Genetic disease of Galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
- •AST or ALT > 2 x normal range
- •Total bilirubin > 2.0 mg/dl
- •CK > 2 x normal range
- •eGFR < 60 mL/min/1.73m2
- •Subject who have drunken habitually (alcohol more than 21 units/week, 1 unit = 10 g = 12.5 mL of pure alcohol) or who are unable to quit drinking during this study
- •Subject who have smoke habitually more than 10 cigarettes/day or who are unable to quit smoking during this study
- •Subject who treated with any investigational drugs within 90 days before the administration of investigational drug
- •Previously donate whole blood within 60 days or component blood within 30 days or transfusion within 30 days
- •Subject who treated with any drug within 30 days can affect absorption, distribution, metabolism, excretion of candesartan or atorvastatin
- •Subject who treated with any Rx only drug or herbal drug within 14 days and any OTC within 7 days
- •History of drug abuse
- •Genetic neuromuscular disorder or family history of neuromuscular disorder
- •Unusual diet affected the absorption, distribution, metabolism, excretion of medications
- •Subjects deemed ineligible by investigator based on other reasons
研究组 & 干预措施
AG1502
Experimental
干预措施: Atorvastatin + Candesartan (Drug)
AG1502
Experimental
干预措施: AG1502 (Drug)
Candesartan + Atorvastatin
Active Comparator
干预措施: Atorvastatin + Candesartan (Drug)
Candesartan + Atorvastatin
Active Comparator
干预措施: AG1502 (Drug)
结局指标
主要结局
Cmax (candesartan cilexetil)
时间窗: 0,0.5,1,2,3,4,5,6,8,10,12,24,48 hours
Cmax (Atorvastatin)
时间窗: 0,0.25,0.5,0.75,1,1.333,1.667,2,3,4,6,8,12,24,48 hours
AUClast (Atorvastatin)
时间窗: 0,0.25,0.5,0.75,1,1.333,1.667,2,3,4,6,8,12,24,48 hours
AUClast (candesartan cilexetil)
时间窗: 0,0.5,1,2,3,4,5,6,8,10,12,24,48 hours
次要结局
未报告次要终点
研究者
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