EUCTR2015-002403-29-NL进行中（未招募）1 期
Pharmacokinetics of new dexamphetamine sustained release tablets and the clinical validation of measuring dexamphetamine in dried blood spots - Dexamphetamine sustained release pharmacokinetics and clinical validation of dried blood spots
Di-AcetylM B.V.0 个研究点开始时间: 2016年7月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Participate in a heroin assisted treatment program
- •2.Have completed at least 80% of the study visits of the CATCH-study;
- •3.Be at least 25 years old;
- •4.Be able and willing to participate in the study treatment and assessments;
- •5.Have provided written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Any intake of dexamphetamine 7 days or less before the start of the proposed study;
- •2.Severe medical (e.g., severe renal or kidney insufficiency/failure, hypertension, glaucoma) or psychiatric problems (e.g., acute psychosis or history of drug-induced psychotic disorder, acute suicidality), which constitute a contraindication for participation;
- •3.(desired) Pregnancy or continued lactation;
- •4.Insufficient command of the Dutch language;
- •5.Current participation in another trial;
研究者
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