NL-OMON39261已完成不适用
A study to evaluate the bioequivalence of Orfadin capsules 20 mg compared to Orfadin capsules 10 mg. An open-label, randomized, cross-over, single-dose study in healthy volunteers. - Nitisinone 20 mg/10 mg capsule BE study
PRA International EDS0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •healthy male and female subjects
- •18-55 yrs, inclusive
- •BMI: 18.5-30.0 kg/m2, inclusive
- •smoking <<= 10 cigarettes per day
排除标准
- •Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor > 50 mL within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
研究者
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