NL-OMON48951已完成不适用
An Open-Label, Randomized, Crossover Pilot Study to Evaluate the Pharmacokinetics and Relative Bioavailability of JZP-324 Formulations vs. Xyrem in Healthy Subjects - JZP 324 BA study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
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 or female
- •- between 18 and 45 years of age, inclusive
- •- BMI between 20 and 30 kg/m2, inclusive, with a body weight at least 60 kilograms
排除标准
- •- Has a clinically significant unstable medical abnormality, chronic disease, or history or presence of significant neurological (including seizure and cognitive disorders) or psychiatric disorder, hepatic, renal, endocrine, cardiovascular (including hypertension), gastrointestinal, pulmonary, or metabolic disease or any other abnormality that could interfere with the pharmacokinetic evaluation of the study drug.
- •- Has a history or the presence of gastrointestinal (including peptic ulcer), hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- •- Is a female subject who is pregnant, nursing, or lactating.
研究者
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