ACTRN12617001251314已完成1 期
Open-Label Study in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Switching from Oral Risperidone to Risperidone Implant (DLP-114)
Delpor Australia Pty Ltd0 个研究点目标入组 17 人开始时间: 2017年8月28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
- 17
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- All
入选标准
- •Healthy adult male and non-pregnant females
排除标准
- •1. Known hypersensitivity to titanium, implant materials or procedure;
- •2. Known hypersensitivity or allergy to lidocaine or any local anesthetic agent of the amide type (local anesthetic used during implant and explant procedures);
- •3. History of abnormal scar formation or family history of keloid formation;
- •4. Disorders of the central nervous system, including psychiatric disorders, behavioral disturbances, cerebrovascular events, depression, bipolar disorder, migraine, Parkinson’s disease.
- •5. History of treatment for marked depression, anxiety, tension, or agitation; currently on medication for asthma; use of any MAOI within 14 days prior to dosing; history of surgery requiring anesthesia within 8 weeks prior to start of dosing;
- •6. Blood or plasma donation within 30 days prior to start of dosing. All subjects will be advised not to donate blood or plasma for six weeks after completing the study.
研究者
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