A randomized, double-blind, parallel, single dose comparative pharmacokinetic study of AryoTrust (Trastuzumab) powder for concentrate for solution for intravenous infusion and ‘HERCEPTIN’ (Trastuzumab) powder for concentrate for solution for intravenous infusion in healthy, adult, male subjects.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- To compare the pharmacokinetics of AryoTrust (Trastuzumab) of AryoGen Pharmed, Iran to ‘HERCEPTIN’ (Trastuzumab) of Roche Registration GmbH after administration of single intravenous (IV) infusion in healthy, adult, male subjects.
研究概览
简要总结
This is a randomized,double-blind, parallel, single dose comparative pharmacokinetic study ofAryoTrust (Trastuzumab) powder for concentrate for solution for intravenousinfusion and ‘HERCEPTIN’ (Trastuzumab) powder for concentrate for solution forintravenous infusion in healthy, adult, male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
To compare the pharmacokinetics of AryoTrust (Trastuzumab) of AryoGen Pharmed, Iran to ‘HERCEPTIN’ (Trastuzumab) of Roche Registration GmbH after administration of single intravenous (IV) infusion in healthy, adult, male subjects.
时间窗: Pre-dose (0.0 hour) and at 0.5 (coinciding with the infusion), 1.0 (coinciding with the infusion), 1.5 (immediately before the end of infusion), 3.0, 6.0, 12.0 and 24.0,48.0, 72.0, 96.0, 168.0, 336.0, 672.0, 1008.0 and 1344.0 hours
次要结局
- To assess and compare the safety and tolerability of AryoTrust (Trastuzumab) of AryoGen Pharmed, Iran to ‘HERCEPTIN’ (Trastuzumab) of Roche Registration GmbH in healthy, adult, male subjects(Incidence of adverse events/ serious adverse events.)