ACTRN12614000444684已完成1 期
IPX237-B14-01: Evaluation of the Pharmacokinetics of Sublingual IPX237 in Healthy Volunteers
Impax Pharmaceuticals,A Division of Impax Laboratories, Inc.0 个研究点目标入组 24 人开始时间: 2014年4月30日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •Healthy volunteers between the ages of 18 and 55 years of age inclusive, weighing at least 60 kg with BMI of 18.0 kg/m2 to 29.5 kg/m2 (inclusive) at the time of informed consent.
排除标准
- •Presence of a clinically significant disorder, including acute or chronic infections or a malignant neoplasm and/or involving disease in one or more of these organ systems: cardiovascular, respiratory, renal, gastrointestinal, immunologic, musculoskeletal, hematologic, dermatologic, hepatic, reproductive, endocrine, or neurologic/psychiatric, as determined by clinical investigators.
- •History of psychosis in self or family.
- •History of or clinical signs of glaucoma.
- •History of or clinical signs of any form of epilepsy or seizures
研究者
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