NCT01447797已完成1 期
Single Dose Open-label Comparative Pharmacokinetic Study to Assess the Pharmacokinetic Characteristics of Irbesartan and Atorvastatin Between Irbesartan/Atorvastatin Combination Tablet and Coadministration of Irbesartan and Atorvastatin Tablets in Healthy Male Subjects
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2011年9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
- 52
- 试验地点
- 1
- 主要终点
- AUC of Irbesartan
研究概览
简要总结
The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of Irbesartan and Atorvastatin in combination as HCP0912
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 and 45
- •Signed informed consent form
- •weight : over 45kg and in the range of ±20% of IBW
排除标准
- •Has a medical history of hypersensitivity to atorvastatin or irbesartan
- •severe Hypotension
- •Not eligible for subject in health examination within 28 days of IP administration
研究组 & 干预措施
HCP0912
Experimental
Irbesartan/Atorvastatin combination tablet
干预措施: HCP0912 / Irbesartan and Atorvastatin (Drug)
Irbesartan and Atorvastatin
Active Comparator
coadministration of irbesartan and atorvastatin
干预措施: HCP0912 / Irbesartan and Atorvastatin (Drug)
结局指标
主要结局
AUC of Irbesartan
时间窗: 0-48 hrs
AUC of Atorvastatin and 2-hydroxy atorvastatin
时间窗: 0-48 hrs
Cmax of Irbesartan
时间窗: 0-48 hrs
Cmax of Atorvastatin and 2-hydroxy atorvastatin
时间窗: 0-48 hrs
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Pharmacokinetic and Safety of Ramelteon Between Adolescents With Insomnia and Healthy AdultsInsomniaNCT00914862Takeda56
已完成
1 期
Evaluate the Pharmacokinetics, Safety, and Tolerability of Alisporivir in Subjects With Hepatic Impairment Compared to Healthy SubjectsHepatic InsufficiencyNCT01860326Debiopharm International SA32
已完成
1 期
Study to Compare and Assess the Safety and Pharmacokinetic Characteristics After Oral Administration of Fimasartan (BR-A-657∙K) in Healthy Elderly and Young Male VolunteersEssential HypertensionNCT00937534Boryung Pharmaceutical Co., Ltd22
已完成
4 期
Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric PatientsPainFeverNCT02583399Cumberland Pharmaceuticals30
已完成
1 期
A Study to Assess the Effect of Hepatic Function on the Pharmacokinetics and Safety of ASP1941Liver DiseaseNCT01187186Astellas Pharma Inc16