NCT01823133已完成1 期
A Randomized, Open Label Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Rosuvastatin in Healthy Male Subjects
LG Life Sciences1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- AUC
研究概览
简要总结
Investigate the pharmacokinetic drug interactions between gemigliptin and rosuvastatin in healthy subjects
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
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age between 20 to 45, healthy male subjects (at screening)
- •BMI between 18 - 27 kg/m2 (at screening)
- •Blood pressure SBP 90-140 mmHg, DBP 60-95 mmHg
- •FPG 70-125mg/dL glucose level (at screening)
- •Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the
排除标准
- •Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)
- •Subject who had GI tract disease that influencable to drug absorption or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
- •Subject who had drug hypersensitivity reaction.(gemigliptin, rosuvastatin, aspirin, antibiotics)
- •Subject who already admitted in other investigator product in 80 days
- •Subject who had whole blood donation in 60 days, or component blood donation in 30 days or transfusion in 30 days currently
研究组 & 干预措施
gemigliptin only
Experimental
Multiple administrations of gemigliptin
干预措施: gemigliptin only (Drug)
rosuvastatin only
Experimental
Multiple administrations of rosuvastatin
干预措施: rosuvastatin only (Drug)
gemigliptin and rosuvastatin
Experimental
Multiple administrations of gemigliptin and rosuvastatin
干预措施: gemigliptin and rosuvastatin (Drug)
结局指标
主要结局
AUC
时间窗: up to 72 hour post dose
to evaluate AUCt of gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin at steady state
Cmax
时间窗: up to 72 hour post dose
to evaluate Cmax of gemigliptin and rosuvastatin at steady state
次要结局
- Tmax(up to 72 hour post dose)
- Cmin(upto 72 hour post dose)
- t1/2β(upto 72 hour post dose)
- Cmax(upto 72 hour post dose)
- AUC(upto 72 hour post dose)
- metabolic ratio(upto 72 hour post dose)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Pharmacokinetic Drug Interaction Study Between Gemigliptin and Irbesartan After Oral Administration in Healthy Male SubjectsHealthyNCT01825850LG Life Sciences30
已完成
1 期
Pharmacokinetic Drug Interaction Study Between Gemigliptin and Glimepiride in Healthy Male SubjectsHealthyNCT01768455LG Life Sciences27
已完成
1 期
A Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis.Rheumatoid ArthritisNCT00365001Hoffmann-La Roche23
已完成
1 期
A Drug Interaction Study of Simvastatin and AlbiglutideDiabetes Mellitus, Type 2NCT01147692GlaxoSmithKline40
撤回
1 期
Pharmacokinetic Interactions of Bisoprolol and RosuvastatinHealthyNCT01925300HK inno.N Corporation