Administration study of preparation containing the Doping Prohibited Substances to healthy adult males

LSI Medience Corporation1 个研究点目标入组 21 人开始时间: 待定最近更新: 2022年3月11日

试验速览

暂无简介。

研究类型: Interventional
干预模型: After preliminary examinations (medical history, current medical history, and safety confirmation items) are conducted on Japanese healthy adult male subjects within 30 days prior to administration of the study drug, 21 of them will be administered the study drug under open-label conditions, and urine and blood samples will be collected from the subjects from the morning following admission until 84 hours after administration of the study drug, in accordance with the study protocol. Upon administration of the study drug and collection of samples, tests and observations will be performed to confirm safety. Each sample will be stored and maintained in a prescribed manner before being subjected to quantitative analysis of unchanged drug and metabolites of the test drug.
主要目的: Other

•BMI more than 18.5 and less than 25.0
•Person who were judged to be appropriate to participate in this study by the principal investigator or the Sub-investigator.

•Those who have had allergic symptoms due to drugs
•Alcohol or drug addicts (including past history)
•Within 2 weeks of the administration of the study drug, those who used medicinal products, over-the-counter drugs and those who consumed supplements, foods containing St. John's wort, grapefruit, or their processed products
•A person who may be treated for any disease or during the study period
•Those who received the study drug or study drug within 16 weeks of the study drug administration, and also study drug administration, or those who received the study drug containing the approved ingredients within 12 weeks of the day
•Person who received blood collection under the following conditions for blood donation etc.
•200 mL or more within 4 weeks of administration, 400 mL or more within 12 weeks of administration(In the case of the component blood donation, within 14 days of the administration day regardless of the blood collection volume)
•Person who weighs less than 50 kg (at the time of prior examination)
•Those who have a history of heart disease, liver disease, kidney disease, or who have high blood pressure, depression, mania, other psychiatric disorders, epilepsy, sleep related disease or history
•Persons who were considered by the Study Investigator or Investigator as inappropriate for this study

Effects of sample collection method: Sample collection time, type and amount of sample collected

发起方

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