EUCTR2016-000307-93-Outside-EU/EEA进行中（未招募）不适用
A randomized, open label, single center, phase I, two way, cross-over study to evaluate the pharmacokinetic comparability of deferasirox new granule formulation with the reference dispersible formulation in healthy subjects.
ovartis Pharmaceuticals Corporation0 个研究点目标入组 38 人开始时间: 2016年3月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Healthy male or female between 18-55 years.
- •- Females of child bearing potential who were willing during the entire study period to use one or more of the acceptable methods of contraception.
- •- Subjects weighing 60-100kg witha body mass index 18-33kg/m²
- •-Serum ferritin >=20ng/mL, total iron-binding capacity in the range of 250-450 ?g/dL, and iron: total iron-binding capacity ratio >= 15% at visit 1.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 38
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- History or presence of hematological disorders
- •-History or presence of ophtalmic symptoms or disorders
- •- History or presence of clinical manifestations of postural hypotension.
- •- History or presence of any active medical conditions or clinically significant findings that might have altered the absorption, distribution, metabolism or excretion of deferasirox, as judged to be relevant by the investigator
- •- Use of investigational drugs within 5 elimination half-lives or participation in any other clinical trial within 4 weeks prior to visit 1, whichever was longer.
研究者
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