NCT02426151已完成1 期
A Randomized, Open Label, Single-dose 2x2 Crossover Study to Compare Pharmacokinetic, Pharmacodynamic Profiles, and Tolerability of EPO (BEPO-A (4000 IU)) and EPO (REPO-A (4000 IU)) in Healthy Male Subjects
LG Life Sciences0 个研究点目标入组 46 人开始时间: 2015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
- 46
- 主要终点
- Cmax and AUClast
研究概览
简要总结
To Compare Pharmacokinetic and Pharmacodynamic Profiles of BEPO-A and REPO-A in Healthy Male Subjects
详细描述
To Compare Pharmacokinetic and Pharmacodynamic Profiles of EPO (BEPO-A (4000 IU)) and EPO (REPO-A (4000 IU)) in Healthy Male 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
- 19 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Agree to all the purposes of the study by signing and dating the Informed Consent;
- •Male, aged between 19 and 40 years, clinically healthy;
- •BMI between 19 and 28;
- •90 mmHg ≤ SBP <140 mmHg, 50 mmHg ≤ DBP < 85 mmHg
排除标准
- •Hemoglobin <13 g / dL
- •Ferritin <20 ng/mL or TIBC > 360 ug/ dL
- •Vitamin B12 < 200 pg/mL or floate < 4 ng/mL
- •%reticulpcyte > 3%
- •platelet < 100,000/ul or > 400,000/ul
- •GFR < 60mL/min/1.73m2
- •Going to or during treatment of the tumor
- •Clinical history of allergy of biological products derived from mammalian albumin or any component of the formulation
- •Clinical history of autoimmune or hereditary anemia
- •A Positive reaction in the nicotine tests
- •Principal Investigator of the study criteria.
研究组 & 干预措施
REPO-A
Active Comparator
Single subcutaneous injection of REPO-A 4000 IU (Roller bottle manufacturing process)
干预措施: REPO-A (Drug)
BEPO-A
Experimental
Single subcutaneous injection of BEPO-A 4000 IU (Bioreactor manufacturing process)
干预措施: BEPO-A (Drug)
结局指标
主要结局
Cmax and AUClast
时间窗: 1D before dosing, 1h, 2, 4h, 7h, 10h,12h, 14h, 2D 0h, 2D 8h, 3D 0h, 4D 0h, 5D 0h, 6D 0h,
次要结局
- AUCinf, Tmax, t1/2β, CL/F, MRTinf (mean residence time) of Erythropoietin(1D before dosing, 1h, 2, 4h, 7h, 10h,12h, 14h, 2D 0h, 2D 8h, 3D 0h, 4D 0h, 5D 0h, 6D 0h,)
研究者
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