JPRN-jRCTs031220009招募中1 期
A multicenter exploratory clinical study of sedation depth and safety of intravenous sedation with remimazolam in healthy Japanese male: A single- and continious-dose ascending study
Goto Takashi0 个研究点目标入组 72 人开始时间: 2022年4月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 45age old（—）
- 性别
- Male
入选标准
- •1. Healthy individuals (equivalent to ASA-PS class 1)
- •2. Sex: male
- •3. Age: between 18 and 45 years old
- •4. BMI: 18.5 kg/m2 or more, less than 30 kg/m2
- •5. Those who voluntarily provided written informed consent upon receiving sufficient explanation and understanding the content of the study
排除标准
- •1. Those who were deemed ineligible for the study based on the results of clinical examination, physiological examinations, electrocardiogram, pulmonary function test, and health examinations for the confirmation of participant characteristics upon screening
- •2. Those with more than 2.5 times higher than the upper limit of the facility criteria of the aspartate transaminase and alanine transaminase levels upon screening and total bilirubin level upon screening that was 1.5 times higher than the facility criteria
- •3. Those treated for severe or poorly controlled (ASA PS class 3 or greater) respiratory diseases (bronchial asthma, etc.), cardiovascular disease (hypertension, etc.), neurological disorders (convulsions, etc.), digestive diseases, liver diseases, kidney disease, hematopoietic diseases, mental illness, endocrine diseases, etc. or with a history of them who were deemed ineligible for the study for security reasons by the principal investigator or sub-investigator
- •4. Those with a history of oversedation or respiratory depression after the administration of benzodiazepines
- •5. Those with a history of hypersensitivity to benzo diazepines (study drug components) or flumazenil
- •6. Those with diseases in which benzodiazepines are contraindicated, such as those with acute angle closure glaucoma and myasthenia gravis, or their symptoms
- •7. Those with a significantly prolonged corrected QT interval (recurrence of QTc > 450 ms) seen on electrocardiogram
- •8. Those with Mallampati class 3 or 4
- •9. Those with high risk of becoming comatosed with respiratory depression due to head injury, bra in tumor, among others
- •10. Those without the ability to provide informed consent due to complications of dementia, etc.
- •11. Those with chronic or acute infection
- •12. Those who used benzodiazepines within 12 months before the administration of the study drug
- •13. Those who had blood sampling of >400 mL (including blood donation) within 3 months before the administration of the study drug, those who had blood sampling of >200 mL (including blood donation) within 1 month before the administration of the study drug, those who donated blood plasma and platelet components within 2 weeks before the administration of the study drug, or those who received blood transfusion within 3 months before the administration of the study drug
- •14. Those who received medication within 2 weeks before the administration of the study drug or those who were on medication
- •15. Those with resting SpO2 of <95% (room air)
- •16. Those with organic brain abnormalities
- •17. Smokers (>10 cigarettes / days) and those who did not agree to quit smoking during the study
- •18. Heavy drinkers (equivalent to 60 g/day of pure alcohol) or those with acute alcohol intoxication and abnormal vital signs
- •19. Those with complications of drug abuse and dependence and alcohol dependence or a history of them
- •20. Those who do excessive exercise (1 week before or during the study period) and those undergoing diet for weight control
- •21. Others who were determined to be ineligible for the study by the principal investigator or sub-investigator
研究者
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