NCT02246855已完成1 期
A Comparison of the Pharmacokinetics, Safety and Tolerance of Two Formulations of a Liquid IVIg (Vigam® Liquid and Gammaplex®) Using Standard and Accelerated Infusion Rates in Healthy Adult Volunteers (Three Treatment Arms)
Bio Products Laboratory2 个研究点 分布在 1 个国家开始时间: 2004年8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
- PK parameters for serum immunoglobulin G (IgG)
研究概览
简要总结
The main object of the study is to compare the AUC0-84, of a single intravenous infusion of Vigam® Liquid (infused at the licensed rate of up to 3mL/min) with Gammaplex® (infused at up to 3mL/min and up to 6mL/min).
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, normotensive, non-smoking male and female volunteers aged 18 to 60 who gave written informed consent and fulfilled all of the inclusion criteria and none of the
排除标准
- •Female volunteers of childbearing potential had a negative pregnancy test before entering the study and had to use either a double barrier method of contraception or use the oral contraceptive pill.
- •Postmenopausal or surgically sterile female volunteers could be enrolled.
- •Exclusion Criteria:
研究组 & 干预措施
Vigam® Liquid infused at up to 3mL/min
Experimental
Gammaplex® (Human Normal Immunoglobulin)
干预措施: Gammaplex® (Human Normal Immunoglobulin) (Biological)
Gammaplex® infused at up to 3mL/min
Experimental
Gammaplex® (Human Normal Immunoglobulin)
干预措施: Gammaplex® (Human Normal Immunoglobulin) (Biological)
Gammaplex® infused at up to 6mL/min
Experimental
Gammaplex® (Human Normal Immunoglobulin)
干预措施: Gammaplex® (Human Normal Immunoglobulin) (Biological)
结局指标
主要结局
PK parameters for serum immunoglobulin G (IgG)
时间窗: Screening, pre-dose (Day 1), 15 min, 4 hr, 24 hr, 30 hr, 48 hr, Days 4, 8, 11, 15, 18, 22, 29, 36, 43, 50, 57, 71, 85
次要结局
未报告次要终点
研究者
研究点 (2)
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