EUCTR2016-000248-32-Outside-EU/EEA进行中（未招募）不适用
A randomized, open-label, single center, phase I, cross-over study to evaluate the pharmacokinetic comparability of deferasirox new tablet formulation with the reference dispersible formulation in healthy adult subjects.
ovartis Pharmaceuticals Corporation0 个研究点目标入组 26 人开始时间: 2016年3月15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
- 26
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 aged 18-55 years
- •-Vital signs (after 3 minutes of rest as measured in the supine position) with the following ranges: oral body temperature 35-37.5°C, sysotlic blood preasure 90-140 mm Hg, diastolic blood preasure 60-90 mm Hg, pulse rate 40-90bpm
- •- Wieght between 60-100kg and body mass index between 18kg/m² and 33kg/m²
- •- Serum ferritin value of >=20ng/mL, total iron binding capacity of 250-370 ?g/dL and iron:TIBC ratio of >=15% at visit 1
- •- Laboratory values within normal ranges that were within 2 weekds priorto starting study treatment, unless deemed not clinically significant by the investigator.
- •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 26
- •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 that included but were not limited to: anemia, recurrent anemia, , iron deficiency, leukemia, lymphoma, etc.
- •- History or presenc of ophtalmic symptoms and/or disorders that included but were not limited to: cataract, retinal changes, glaucoma, optic neuris, etc. with the exception of refractory disorders (e.g. myopia, astigmatism).
研究者
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