JPRN-jRCTs041220104已完成1 期
Clinical Pharmacokinetic study of Naloxone Hydrochloride film
Ryuji Hayashi0 个研究点目标入组 7 人开始时间: 2022年12月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
研究概览
简要总结
In this clinical trial, we examined effects of intraoral films of naloxone hydrochloride with 3 doses (low dose of 0.56mg/body, middle dose of 2.2mg/body and high dose of 8.9mg/body) in six healthy subjects. Then, plasma concentration analysis and pharmacokinetics analysis were performed. Dose-dependency was observed by blood concentration and AUC. Tmax, T1/2, and MRT were respectively almost comparable.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 50age old（—）
- 性别
- All
入选标准
- •1) healthy adult whose age is 20-50 years old, male or female Japanese
- •2) body weight is 45-75 kilo grams and BMI is 18.5-25
- •3) participant who can understand and comply the study plan and give the informed concent in writing with his or her self-judgement
排除标准
- •1) anybody who has the history of malignant disease
- •2) anybody who has certain chronic disease such as heart disease, liver injury, renal dysfunction, cerebrovascular disease, collagen disease, diabetic mellitus, dyslipidemia, hypertension or others
- •3) anybody who has daily medicine (including herbal medicine)
- •4) anybody whose serum creatin is equal or more than 1.5 mg/dL
- •5) anybody whose serum asparagine acid aminotransferase or alanine aminotransferase is equal or more than twice for institutional normal range
- •6) anybody whose blood hemoglobin is less than 10 g/dL
- •7) anybody who needs medicine because of abnormal value of screening test
- •8) anybody who has allergy history for Naloxone
- •9) anybody who has severe allergic history for any drug
- •10) anybody who is pregnant, who is lactating, or who may become pregnant during this clinical trial.
- •11) anybody who is positive for serum test of HBsAg, HCVAb, HIVAg or HIVAb
- •12) anybody who is considered to be inappropriate for this study by the principal investigator
研究者
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