NL-OMON49206已完成不适用
A phase I, open-label, randomized, three-way cross-over study comparing bioavailability of two formulations and assessing the food effect on tablet formulation after PXL770 single oral dose in healthy subjects - Bioavailability of two formulations of PXL770 after a single dose in HV
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Poxel SA
- 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 99（—）
入选标准
- •1. Gender : male or female.
- •2. Age : 18 to 55 years, inclusive, at screening.
- •3. Body mass index (BMI) : 18.0 to 30 kg/m2, inclusive, at screening.
- •4. Weight : >=50 kg at screening.
- •5. Status : healthy subjects.
排除标准
- •1. Previous participation in any clinical study with PXL770 (only if subject
- •received study drug).
- •2. Employee of PRA or the Sponsor.
- •3. Mental handicap, legal incapacity, or any history of clinically important
- •emotional and/or psychiatric illness.
- •4. Vulnerable subjects (e.g. persons kept in detention).
- •5. History of relevant drug and/or food allergies.
研究者
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