jRCT1071240052招募中不适用
The administration study of hematopoietic agents, diuretics and anabolic steroids in healthy adult males. (The administration study of hematopoietic agents, diuretics and anabolic steroids in healthy adult males.)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 18
- 主要终点
- -
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
- 18age old over 至 35age old under（—）
- 性别
- Male
入选标准
- •Age: 18 to 35 years (at the time when consent is given)
- •BMI at the time of prior examination :
- •Males 18.5 or more and less than 25.0
- •Individuals who the principal or subinvestigator believes to be acceptable for the study
排除标准
- •Those who have experienced allergic symptoms due to drugs.
- •Those suspected of having an infectious disease, including the new coronavirus.
- •Those currently undergoing treatment for any disease or those who may undergo treatment during the study period.
- •Those who are alcoholic or drug dependent, or have a history of depression.
- •Those with a history of the following diseases or those suspected of having them
- •Study Drug-1 to Study Drug-2 :
- •Myocardial infarction, pulmonary infarction, cerebral infarction, and other thromboembolic diseases, hypertension, and hyperkalemia
- •Study Drug-3 to Study Drug-4 :
- •Renal dysfunction, hyperkalemia, Addison's disease, coronary arteriosclerosis, cerebral arteriosclerosis, liver dysfunction, convulsive predisposition such as epilepsy
- •Study Drug-5 to Study Drug-6 :
- •Androgen-dependent tumors, prostatic hyperplasia, heart disease, kidney disease, liver disease
- •Those who have used prescription drugs or over-the-counter drugs within 5 weeks of taking the study drug
- •Those who have used supplements, western medicine, or other drugs within 1 week of taking the test drug. Those who have consumed food containing St. John's wort, grapefruit, or processed products thereof.
- •Those who have received other investigational or study drugs within 16 weeks of the administration of the study drug, or those who have received investigational or study drugs containing approved ingredients within 12 weeks.
- •Those who have had 200mL or more of blood drawn or transfused within 30 days of the administration of the study drug, or 400mL or more within 90 days, or those who have donated blood components within 14 days.
- •Those who weigh less than 50kg at the time of the pre-examination, and those with Hb value of 16 or more and Ht value of 50% or more for study drug-1 to study drug-
- •Those whose urine collected during the pre-test was found to contain prohibited doping substances or substances that affect doping tests
- •Those who consume excessive amounts of alcohol on a daily basis, and those who do not agree to refrain from alcohol consumption during the test period
- •Those who are deemed inappropriate for participation in this study by the principal investigator or co-investigator
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 study drugs
- Detectable period of metabolites of study drugs
研究者
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