NCT00277199已完成1 期
Study to Compare the Pharmacokinetics of CD-CHO1 Process BMS-188667 to DE Process BMS188667 in Healthy Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2002年9月最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To test pharmacokinetics
研究概览
简要总结
Study to Compare the Pharmacokinetics of CD-CHO1 Process BMS-188667 to DE Process BMS-188667 in Healthy Subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed consent form
- •Healthy subjects as determined by good health as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations.
- •Body weight for all subjects will be <- 100 kg.
- •body Mass Index (BMI) of 18-30 kg/m2 inclusive; BMI = weight (kg)/[height (m)]2
- •Men and women (not nursing, not prgnant), who are at least 18 years of age. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study for at least 4 weeks before and for up to 10 weeks after the infusion of BMS-188667 in such a manner that the risk of pregnancy is minimized.
排除标准
- •WOCBP and males who are unwilling or unable to use an acceptable method to avoid pregnancy for up to 10 weeks after he infusion of BMS-
- •WOCBP must also be using an acceptable method of contraception for at least 1 month before dosing.
- •Women who are pregnant ore breast-feeding.
- •Women with positive pregnanacy tes on enrollment or prior to study drug administration.
- •History or current evidence of any signiicant acute or chroinic medical illness
结局指标
主要结局
To test pharmacokinetics
次要结局
- To test Safety and immunogenicity
研究者
研究点 (1)
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