EUCTR2016-000308-28-Outside-EU/EEA进行中（未招募）不适用
A randomized, open label, six sequences, cross-over study in healthy Japanese subjects to evaluate the pharmacokinetic comparability of deferasirox granule formulation with the reference dispersible tablet formulation (Exjade)
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ovartis
- 入组人数
- 97
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 subjects between 20 and 45 years of age; subjects weighing between
- •50 kg and 100 kg with a body mass index between 18.5 and 25 kg/m2; serum ferritin value = 20 ng/mL,
- •total iron binding capacity in the range of 250 to 450 µg/dL, and iron/TIBC ratio = 15% at Screening
- •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 97
- •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
- •ophthalmic symptoms and/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 alter the absorption, distribution, metabolism or excretion of deferasirox, as judged to be relevant
- •by the Investigator; any use of deferasirox.
研究者
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