Evaluation study for the effect of dl-methylephedrine and pseudoephedrine.

Not Applicable

• Conditions: healthy

• Registration Number: JPRN-jRCTs031200205
• Lead Sponsor: Tateno Amane

Brief Summary

The effects of dl-methylephedrine and pseudoephedrine on brain function were comparable to those of placebo.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-26
• Study Completion: 2022-02-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified