jRCT1071230045已完成不适用
The administration study of hematopoietic agents, antidiuretics, plasma substitutes and cortisol synthesis inhibitor in healthy adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 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
- 20age old over 至 35age old under（—）
- 性别
- All
入选标准
- •a. Age: 20 to 35 years (at the time when consent is given)
- •b. BMI at the time of prior examination :
- •Males 18.5 or more and less than 25.0, Female 17.6 more and less than 26.4
- •c. Individuals who the principal or subinvestigator believes to be acceptable for the study
排除标准
- •a. Those who have a history of allergic symptoms due to drugs;
- •b. Those who are suspected of having an infectious disease, including SARS CoV 2 infection;
- •c. Those who are undergoing any therapy now or will undergo any therapy during the study period;
- •d. Those who were or are alcoholic, drug addicted, or depressed;
- •e. Those who have a history of or are suspected of having one of the following diseases;
- •Study Drug 1 to Study Drug 5:
- •Cerebral infarction, myocardial infarction, thromboembolism such as pulmonary embolism, cardiovascular disease, stroke, central hypothyroidism, hypertension, malignant tumor, proliferative diabetic retinopathy, macular edema, exudative age related macular degeneration, retinal vein occlusion and liver dysfunction
- •Study Drug 6 to Study Drug 9:
- •myocardial infarction, pulmonary infarction, cerebral infarction, hypertension and hyperkalemia
- •Study Drug 10:
- •Hyponatremia, habitual or psychogenic polydipsia, fluid retention requiring treatment with diuretics, syndrome of inappropriate secretion of antidiuretic hormone, renal dysfunction, cardiovascular disease with hypertension, severe disease, Arteriosclerosis, coronary artery thrombosis, angina pectoris, heart failure and anterior pituitary insufficiency
- •Study Drug 11:
- •Congenital long QT syndrome, congestive heart failure, bradyarrhythmia, hypokalemia, hypomagnesemia and other electrolyte abnormalities, hypertension, liver dysfunction, adrenal cortical dysfunction
- •Study Drug 12:
- •Pulmonary edema, congestive heart failure, renal dysfunction such as renal failure with oliguria or anuria, intracranial hemorrhage, hypernatremia, hyperchloremia, bleeding diathesis
- •f. Those who have a history of using ethical or over the counter drugs within five weeks ahead of administrating the study drug;
- •g. Those who have a history of consuming supplements, foods containing St. John's Wort, grapefruit, or its processed products within one week ahead of administrating the study drug
- •h. Those who have a history of treatment with other investigational or study drugs within 16 weeks before administration of the study drug or treatment with other investigational or study drugs containing approved ingredients within 12 weeks before administration of the study drug;
- •i. Those who have a history of having 200 mL or more of blood or 400 mL or more of blood sampled within 30 or 90 days before administrating the study drug, respectively, or a history of blood component transfusion within 14 days or whole blood transfusion within 90 days before administrating the study drug;
- •j. Those who weigh less than 50 kg for a male and less than 40 kg for a female at the time of preliminary
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
相似试验
招募中
不适用
Study on drug blood concentration, effectiveness, safety, and drug tolerance using residual samples of permission system and notification type antimicrobial druginfectious diseaseJPRN-UMIN000030456Keio University Hospital3,250
暂停
2 期
make herabal tablet and herbal churna from rasnasaptak decoction and use in amavataCTRI/2019/04/018732parul ayurved pharmacy
尚未招募
3 期
Comparative Clinical Study of Kariradi Vaginal Wash and Clotrimazole in ShwetapradarCTRI/2024/07/069717DrApurva Chandrakant Karande
尚未招募
1 期
Clinical study of Darvyadi Granules in Iron Deficiency Anaemia.CTRI/2020/04/024459Parul University
已完成
不适用
A clinical trial to measure the cytotoxic activity of lymphocytes increased by dasatinib treatmentchronic phase chronic myeloid leukemiaJPRN-UMIN000006501Juntendo University School of Medicine5