NCT02609711Unknown1 期
Investigate a Interaction of Candesartan and Atorvastatin in Healthy Male Sugjects
Ahn-Gook Pharmaceuticals Co.,Ltd2 个研究点 分布在 2 个国家目标入组 90 人开始时间: 2015年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- AUClast (Atorvastatin)
研究概览
简要总结
primary object : Evaluate pharmacokinetic drug-drug interaction of Candesartan and Atorvastatin
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Adult healthy males 20 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
结局指标
主要结局
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
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 (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
研究点 (2)
Loading locations...
相似试验
已完成
1 期
CKD-337 Drug Interaction StudyDyslipidemia (Fredrickson Type Ⅱa)Dyslipidemia (Fredrickson Type Ⅱb)NCT02066207Chong Kun Dang Pharmaceutical30
Unknown
1 期
Investigate a Pharmacokinetic Characteristics and the Safety of AG1502 in Healthy Male SubjectsHealthy Male SubjectsNCT02614352Ahn-Gook Pharmaceuticals Co.,Ltd60
已完成
2 期
Efficacy and Safety of Atorvastatin in Combination With Radiotherapy and Temozolomide in GlioblastomaGlioblastoma MultiformeNCT02029573King Fahad Medical City36
已完成
1 期
Drug-drug-interaction Study of Candesartan, Amlodipine and AtorvastatinHealthy VolunteersNCT04245046Midas Pharma GmbH18
已完成
4 期
Association Between Systemic Exposure of Atorvastatin and Metabolites and Atorvastatin-induced MyotoxicityMyopathyNCT00120055University of Oslo School of Pharmacy