jRCT1001220001已完成不适用
Administration study of long-acting growth hormone preparations in healthy adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 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
- All
入选标准
- •Men BMI18.5 or more but less than 25.0 at the time of prior examination.
- •Women: BMI 17.6 or more and less than 26.4 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
- •Subjects who have had allergic symptoms due to drugs
- •Subjects who are being treated for some disease or who may receive treatment during the study period
- •Those who are suspected of suffering from or have a history of the following diseases
- •Test drug-1
- •benign intracranial hypertension, hypoadrenocorticism, diabetes, diabetic complications, brain tumor,
- •Heart disease, renal dysfunction, liver dysfunction
- •Test drug-2
- •malignant tumor, hypothyroidism, hypoadrenocorticism, diabetes, brain tumor, heart disease,
- •renal dysfunction
- •Subjects who are alcoholic or drug dependent, or have a history of depression.
- •Subjects who used ethical drugs or over-the-counter drugs within 2 weeks of the scheduled administration of the study drug
- •Subjects who took supplements, foods containing St. John's wort, grapefruit, or processed products thereof within 1 week of scheduled administration of the study drug
- •Subjects who received another investigational drug or investigational drug within 16 weeks of the scheduled administration date of the investigational drug, or an investigational drug or investigational drug containing an approved ingredient within 12 weeks
- •Subjects who received 200 mL or more of blood within 30 days of the scheduled administration of the study drug, 400 mL or more of blood within 90 days, and those who received component blood donation within 14 days of the scheduled administration of the study drug.
- •Subjects weighing less than 40kg and 90kg or more at the time of pre-examination
- •Those who are suspected of having a new coronavirus infection
- •Lactating women, pregnant women, and those who may become pregnant during the study period
- •Subjects who are judged inappropriate for participation in this study by the principal investigator or subinvestigator
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
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