jRCT1071210006已完成不适用
Administration study on preparation of testosterone undecanoate to healthy adult males
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 主要终点
- detectable period of the unchanged drug
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
- •Person 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
- •Person who has caused allergic symptoms due to the study drug or the component of the study drug.
- •Person who is being treated for any disease or who may be treated during the test period.
- •A person suspected of having the following diseases or a person with a medical history.
- •Tumor, cancer, liver disease, kidney disease, heart disease, diabetes, blood coagulation disorder, prostatic hyperplasia, sleep Apnea
- •Alcohol or drug dependents, depression or those with a medical history.
- •Those who are confirmed negative by SARS-CoV-2 test or who are suspected of having a new coronavirus infection.
- •A person who used a medicinal or over-the-counter medication within 2 weeks of the scheduled administration of the study drug.
- •Those who have taken one or more supplements, foods containing Hyperethesia, grapefruit or their processed products within one week of the scheduled administration of the study drug.
- •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.
- •Patients 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.
- •Person who weighs less than 50 kg at the time of pre-examination.
- •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
detectable period of the unchanged drug
The evaluation on analysis method by examining the detectable period of the unchanged drug
detectable period of the metabolite of the test drug
The evaluation on analysis method by examining the detectable period of the metabolite of the test drug
次要结局
未报告次要终点
研究者
相似试验
已完成
不适用
Administration study on preparation of testosterone undecanoate to healthy adult malesJPRN-jRCT1071210006Yonemura Takuma8
招募中
3 期
Testosterone therapy for the treatment of nonalcoholic fatty liver diseaseNonalcoholic fatty liver diseaseACTRN12619000701123Austin Health120
已完成
4 期
Testosterone for gender dysphoria in transgender meDepressionTransgender healthGender dysphoriaSuicideMetabolic and Endocrine - Other endocrine disordersMental Health - DepressionMental Health - SuicideACTRN12621000716864niversity of Melbourne64
已完成
不适用
Examination of the usefulness of testosterone cream for Late Onset Hypogonadism syndromeOH SyndromeJPRN-UMIN000029540Chibanisi-General Hospital200
已完成
不适用
Administration study of Testosterone ester in healthy adult malesjRCT1071220039LSI Medience Corporation7