NCT02246842已完成1 期
A Randomised Study Comparing the Pharmacokinetics and Tolerance of D-Gam® 1500IU to Rhophylac® 1500IUin Rh-D-negative Healthy Volunteers.
Bio Products Laboratory2 个研究点 分布在 1 个国家开始时间: 2004年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
- 主要终点
- Cmax for anti-D
研究概览
简要总结
The primary objective of the study was to compare peak serum anti-D levels (Cmax) of BPL's D-Gam® 1500 IU to Rhophylac® 1500IU in RhD-negative healthy volunteers.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Ages of 18 and 55 years
- •Bodyweight of 50-85kg.
排除标准
- •Clinically relevant abnormalities at physical examination, ECG or laboratory tests.
研究组 & 干预措施
D-Gam®
Experimental
D-Gam® (human anti-D immunoglobulin)
干预措施: D-Gam® (human anti-D immunoglobulin) (Biological)
Rhophylac®
Active Comparator
Human Anti-D Immunoglobulin
干预措施: Rhophylac® (human anti-D immunoglobulin) (Biological)
结局指标
主要结局
Cmax for anti-D
时间窗: Pre-dose, 1, 8, 24, 32, 48, 72 & 96 hours; 1, 2, 3, 4, 5, 6, 8, 10, 12 & 14 weeks post-dose
次要结局
未报告次要终点
研究者
研究点 (2)
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