ACTRN12613001057774已完成不适用
IPX203-B13-02:Pharmacokinetics of IPX203 and Levodopa formulations in healthy volunteers
Impax Laboratories, Inc. Acting through its Impax Pharmaceuticals Division0 个研究点目标入组 20 人开始时间: 2013年9月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- Male
入选标准
- •Healthy males between 18 years and 65 years of age inclusive at the time of informed consent.
排除标准
- •Presence of a clinically significant disorder involving bleeding or hematologic or cardiovascular system abnormalities, acute infections, respiratory, renal, gastrointestinal, immunologic, hepatic, reproductive, endocrine, or neurologic system(s), or psychiatric disease (as determined by the Investigator)
- •History of peptic ulcer disease or surgical procedure of the stomach, the small intestine, or the large intestine
- •History of glaucoma
- •Suspicious skin lesions or history of melanoma
- •History of neuroleptic malignant syndrome (NMS) or nontraumatic rhabdomyolysis
- •Subject has smoked or used tobacco products or nicotine products (patches, gums, etc.) within 60 days prior to Period 1 dosing; subjects does not agree to abstain from tobacco or nicotine products throughout the study.
研究者
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