NL-OMON45837已完成不适用
An exploratory, open-label, randomized, 2 treatments, 2 periods, 2 sequences crossover study to assess the pharmacokinetics of two FT218 batches (single dose administered at the dose of 6g) in healthy volunteers - Exploratory PK study for FT218
Flamel Ireland Ltd trading under the business name Avadel Ireland0 个研究点目标入组 20 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
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 99（—）
入选标准
- •- healthy male and female subjects
- •- 20-50 yrs, inclusive
- •- BMI: 18.0-28.0 kg / m2, inclusive
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. Donation or loss of more than 100 mL of blood within 60 days prior to the first study drug administration. Donation or loss of more than 1.5 liters of blood (for men) / more than 1.0 liters of blood (for women) in the 10 months prior to the first study drug administration
研究者
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