JPRN-jRCTs031200205已完成未知
A randomoized, placebo-controlled, double-blind, comparative study to evaluate the effects of dl-methylephedrine and pseudoephedrine on dopamine transporter and brain function in healthy subjects.
Tateno Amane0 个研究点目标入组 8 人开始时间: 2020年11月26日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 8
研究概览
简要总结
The effects of dl-methylephedrine and pseudoephedrine on brain function were comparable to those of placebo.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 40age old（—）
- 性别
- Male
入选标准
- •1) Subjects who are 20 years old or older and younger than 40 years old when obtaining consents
- •2) Subjects with no history of psychiatric and/or neurological disorders
- •3) Subjects with normal BMI (18.5-25)
- •4) Subjects without the history of smoking
- •5) Subjects who have the ability to provide informed consent and adhere to the protocol.
排除标准
- •1) Subjects who are contraindicated for dl-methylephedrine or pseudoephedrine.
- •a) taking cathecholamines
- •b) with a history of hypersensitivity to dellegra or compouds similar in chemical structure to pseudoephedrine (ephedrine or methylephedrine)
- •c) with severe hypertension
- •d) with severe coronary aretery disease
- •e) with angle-closure glaucoma
- •f) with urinary retention
- •g) with a hisotry of insomnia, dizziness, weakness, tremor, arrhythmia due to sympathomimetics
- •2) Subjects who are subject to careful administration of dl-methylephedrine or pseudoephedrine.
- •a) with hyperthyroidism
- •b) with hypertension
- •c) with heart disease
- •d) with diabetes mellitus
- •e) with elevated intraocular pressure
- •f) with prostatic hypertrophy
- •g) with renal dysfunction
- •3) Subjects who have gastrointenstinal symptoms when taking lactose
- •4) Subjcts who received drug therapy within 1 week before obtaining consent
- •5) Subjects who are contraindicated for the use of MRI
- •6) Subjects who took cafein (by 2 days before the test) or alcohol (by the day before the test).
- •7) Subjects who has been exposed to radiation by job-related exposuer or therapy in one year exceeding 15mSv.
- •8) Subjects who have received contrast agents (X-ray, MRI) or radiopharmaceuticals within 2 days of the examination, or plan to do the day after the examination.
- •9) Athletes at the competition level
- •10) Subjects who do not agree to notify the results of the examination which requires treatment
- •11) Subjects who are judged as not suitable for participation in this study.
研究者
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