Administration study of Testosterone ester in healthy adult males

LSI Medience Corporation0 个研究点目标入组 7 人开始时间: 2022年9月5日最近更新: 2024年2月1日

试验速览

阶段: 不适用
状态: 已完成
发起方: LSI Medience Corporation
入组人数: 7
主要终点: -

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Single Arm Study
干预模型: Single Assignment
主要目的: Other
盲法: Open(masking Not Used)

入排标准

年龄范围: 20age old over 至 35age old under（—）
性别: Male

入选标准

•Japanease with BMI 18.5 or more and less than 25.0 at the time of prior examination. Person who is judged by Principal investigator or Sub-investigator that there is no problem with participation in the test.

排除标准

•A person who has caused allergic symptoms due to the study drug or the component of the study drug. 2) A person who is being treated for any disease or who may be treated during the test period. 3) A person suspected of having the following diseases or a person with a medical history. Androgen-dependent malignancies (eg prostate cancer), heart disease, renal disease, cancer. 4) Alcohol or drug dependents, depression or those with a medical history. 5) A person who used a medicinal or over-the-counter medication within 2 weeks of the scheduled administration of the study drug. 6) A person who has taken one or more supplements, foods containing Hyperethesia, grapefruit or their processed products within one week of the scheduled administration of the study drug. 7) A person who has received another investigational drug or investigational drug within 16 weeks of the scheduled study drug administration date, or an investigational drug or investigational drug containing an approved component within 12 weeks. 8) A person who received blood of 200 mL or more within 30 days of the scheduled administration of the study drug and 400 mL or more within 90 days and those who received blood donation of the component within 14 days of the scheduled administration. 9) A person who weighs less than 50 kg at the time of pre-examination. 10) A person who is confirmed negative by SARS-CoV-2 test or who are suspected of having a new coronavirus infection. 11) A person who has been judged by the Principal investigator or Sub-investigator to be inappropriate to participate in this test.

结局指标

主要结局

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

次要结局

Detectable period of unchanged and metabolites of test drugs

研究者

发起方

LSI Medience Corporation

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