NL-OMON48189已完成不适用
An open*label, randomized, 3*period crossover study to determine the relative bioavailability of ASN120290 from a film*coated tablet given under fasted and fed conditions as compared to a capsule given under fasted conditions in healthy subjects - ASN120290-103-EU (CS0320)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
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
- •Deemed healthy on the basis of medical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if, in the opinion of the Investigator, the finding is (a) unlikely to introduce additional risk to the subject, (b) will not interfere with study procedures or confound study results and (c) is not evaluated as clinically significant.;Subjects must be between 18 and 75 years of age, inclusive, at Screening.;Male healthy volunteer, or women of non*childbearing potential (i.e. postmenopausal [the last spontaneous menstrual period was at least 12 months ago, and FSH at Screening confirms post*menopausal status (FSH *30 U/L)], or has no uterus, ovaries or fallopian tubes or has their fallopian tubes tied).;For more inclusion criteria please refer to the protocol.
排除标准
- •Women who are pregnant, or lactating, or of child-bearing potential.;History of epilepsy or seizures, other than benign febrile convulsions in childhood.;Positive result for suicidal ideation or behavior using the C*SSRS at Screening.;For more exclusion criteria please refer to the protocol.
研究者
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