Methylephedrine Central and Peripheral Action Studies
- Conditions
- healthy
- Registration Number
- JPRN-jRCTs031220492
- Lead Sponsor
- Tateno Amane
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 20
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
Research subjects who fall into any one of the following categories will be excluded from this study
1) Subjects receiving catecholamine preparations (adrenaline, isoproterenol, etc.)
2) Subjects with a history of hypersensitivity to compounds of similar chemical structure (preparations containing ephedrine hydrochloride or methyl ephedrine hydrochloride)
3) Patients with a history of insomnia, dizziness, weakness, tremor, or irregular heartbeat caused by sympathomimetic drugs
4) Patients who have been diagnosed with any of the following diseases
(hyperthyroidism, hypertension, cardiac disease, diabetes, benign prostatic hypertrophy, renal dysfunction, disease causing urinary retention, glaucoma or other diseases causing high intraocular pressure)
5) Patients with a history of gastrointestinal symptoms upon lactose intake
6) Patients who have received drug therapy within one week prior to the scheduled date of the first dose of medication
7) Those who are scheduled to participate in the brain function test and are wearing a device (cardiac pacemaker, cerebral aneurysm clip, etc.) that is affected by the high magnetic field of the MRI machine, or have a machine or metal in their body
8) Persons who have consumed caffeine within 2 days prior to the motor function test and brain function test, or alcohol at least one day prior to the test
9) Those who have been exposed to more than 15 mSv (millisievert) per year due to radiation exposure from work or radiation therapy (15 mSv is equivalent to 3-4 x-rays of the stomach)
10) Persons who have received radiopharmaceuticals between two days prior to the PET scan and the day after the PET scan, or are scheduled to receive such contrast media or radiopharmaceuticals on the day after the PET scan.
11) Persons who wish to participate in a competition
12) Persons who do not agree to be notified of the results of the tests obtained in this study, if they are determined to be in need of treatment by the principal investigator or a physician in charge of the study.
13) Any other person who is deemed inappropriate to participate in this study by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximal oxygen uptake and exercise duration by exercise stress test
- Secondary Outcome Measures
Name Time Method