NCT01929070已完成1 期
A Pilot Study to Evaluate the Pharmacokinetics of Omega-3 Between Rosuvastatin and Omega-3 Coadministration and HCP1007 in Healthy Male Volunteers
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2013年2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
- 12
- 试验地点
- 1
- 主要终点
- Cmax_adj of DHA and EPA
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics of omega-3 between rosuvastatin and omega-3 coadministration and HCP1007 in healthy male volunteers.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult male aged 20 to 55 years
- •A body mass index between 19 and 27 kg/m2
排除标准
- •History of hepatobiliary, renal, gastrointestinal, respiratory, musculoskeletal, endocrinal, hemato-oncologic or cardiovascular disease
- •SBP < 90 or ≥ 150 mmHg, DBP < 60 or ≥90 mmHg
- •Use of herbal medicine within 30 days, prescriptive medicine within 14 days, or over-the-counter drug within 7 days
- •Heavy alcohol consumption (140 g/day)
研究组 & 干预措施
Group 1
Experimental
- R1: Coadministration of Crestor 5mg 4tab and Omacor capsupe 1g 4cap in the fasting state
- R2: Coadministration of Crestor 5mg 4tab and Omacor capsupe 1g 4cap on the high-fat diet
- T1: Single-dose of HCP1007 1g/5mg 4 cap in the fasting state
- T2: Single-dose of HCP1007 1g/5mg 4 cap on the high-fat diet
R1 -> T2 -> R2 -> T1
干预措施: HCP1007 (Drug)
Group 1
Experimental
- R1: Coadministration of Crestor 5mg 4tab and Omacor capsupe 1g 4cap in the fasting state
- R2: Coadministration of Crestor 5mg 4tab and Omacor capsupe 1g 4cap on the high-fat diet
- T1: Single-dose of HCP1007 1g/5mg 4 cap in the fasting state
- T2: Single-dose of HCP1007 1g/5mg 4 cap on the high-fat diet
R1 -> T2 -> R2 -> T1
干预措施: Omarco and Crestor (Drug)
Group 2
Experimental
R2 -> R1 -> T1 -> T2
干预措施: HCP1007 (Drug)
Group 2
Experimental
R2 -> R1 -> T1 -> T2
干预措施: Omarco and Crestor (Drug)
Group 3
Experimental
T1 -> R2 -> T2 -> R1
干预措施: HCP1007 (Drug)
Group 3
Experimental
T1 -> R2 -> T2 -> R1
干预措施: Omarco and Crestor (Drug)
Group 4
Experimental
T2 -> T1 -> R1 -> R2
干预措施: HCP1007 (Drug)
Group 4
Experimental
T2 -> T1 -> R1 -> R2
干预措施: Omarco and Crestor (Drug)
结局指标
主要结局
Cmax_adj of DHA and EPA
时间窗: -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h (on the high-fat diet only)
AUClast_adj of DHA and EPA
时间窗: -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h (on the high-fat diet only)
次要结局
- Cmax of DHA, EPA(-24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet))
- AUClast of DHA, EPA(-24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet))
- AUClast of DHA and EPA(-24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet))
- tmax of DHA and EPA(-24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet))
- t1/2 of DHA and EPA(-24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet))
- AUCinf of DHA and EPA(-24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
to Investigate the Pharmacokinetic Interactions and Safety Between Rosuvastatin and Ezetimibe in Healthy Male VolunteersHealthyNCT02289430NVP Healthcare59
招募中
4 期
Atmeg (Atorvastatin and Omega-3 Combination) and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined DyslipidemiaDyslipidemiasAtherosclerosisDiabetes Mellitus, Type 2NCT05365438Seoul National University Bundang Hospital105
撤回
1 期
Crossover Evaluation of Effect of Atorvastatin on PK of Irinotecan in CRC Patients Receiving FOLFIRIAdvanced Adenocarcinoma of the Colon or RectumNCT01605344UNC Lineberger Comprehensive Cancer Center
已完成
1 期
Investigation of Pharmacokinetic Interaction Between Rosuvastatin and Olmesartan in Healthy Male VolunteersHealthyNCT01831479Severance Hospital36
已完成
1 期
A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Rosuvastatin in Healthy Male SubjectsHypertensionNCT02704702Boryung Pharmaceutical Co., Ltd36