Administration study of lomerizine to healthy adult males

LSI Medience Corporation1 个研究点目标入组 10 人开始时间: 待定最近更新: 2018年12月17日

试验速览

暂无简介。

研究类型: Interventional
干预模型: After a preliminary examination (Items: medical history, current medical history, and safety confirmation) on Japanese healthy adult men within 30 days before the test drug administration, 10 of them as subjects are administered it in an open-label manner and sample collection on the subjects are conducted. Each sample is managed according to the protocol and to quantitative analysis of the unchanged form and metabolites of the test drug.
主要目的: Other

•The weight (kg) / height (m) 2 :18.5 or more and less than 25.0 at the time of a prior inspection. There is consent to clinical test participation.
•Nationality Japanese

•A person who had shown symptoms of allergy caused by this test drug or its composition.
•A person who is suffering from Intracranial hemorrhage, cerebral infarction, liver disease, Parkinson's disease, depression and who is suspected to have these diseases.
•A history of alcohol or drug addiction,
•Under the medical treatment or it may treat of a certain disease,
•Ethical or OTC pharmaceuticals administered within two weeks before scheduled administration of the study drug, Supplement, grapefruit or its products, or foods coating Western St. John's consumed within one week before scheduled administration of the study drug.
•Not less than 200mL of blood is collected within 30 days or not less than 400mL of blood is collected within 90 days before scheduled administration of the study drug.
•Weight: less than 50kg (at the time of a prior inspection),
•A person shall not have a schedule of consultation of another hospital until this administration study.
•A person judged unfit of this study by responsible doctor

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

发起方

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