NCT05816681已完成1 期
An Open-label, Randomized, Multiple Dose, Parallel Study to Assess Elemental Impurities Level After Multiple Administration of DWJ1230 or DWB2001 in Subjects With Functional Diarrhea or Irritable Bowel Syndrome With Predominant Diarrhea(IBS-D)
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年8月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the concentration of lead in blood after administration of Investigational Product
研究概览
简要总结
This study aims to assess elemental impurities level after dministration of dioctahedral smectite in subjects with functional diarrhea or irritable bowel syndrome with predominant diarrhea. Male or female subjects aged between 19 and 60 years will participate in the study. The study design is an opne-label, randomized, multiple dose paraller study. The patients were randomly assigned to DWJ1230 or DWB2001. It is intended that a total of 60 subjects will be enrolled to ensure that at least 24 subjects will complete the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with chronic functional Diarrhea. (included Irritable Bowel Syndrome with perdominant diarrhea(IBS-D)).
- •Male or Female subjects aged between 19 and 60 years at screening.
- •Body Mass Index(BMI) between 18 and 27kg/m2 in male, 17 and 26kg/m2 in female. ※ BMI (kg/m2) = body weight (kg)/[height (m)]2
- •Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information.
排除标准
- •No history or clinically significant symptoms or severe disease, including cardiac, neurological, pulmonary, hepatic, biliary, gastrointestinal, endocrinologic, or renal disorders, or cancer.
- •Identified or strongly suspected organic cause to diarrhea.
- •Celiac disease or Intestinal malabsorption, Unspecified intestinal malabsorption.
- •History of any serious adverse reaction or adverse event or hypersensitivity to any component of investigational product.
- •Constipation, Iron deficiency anaemia, Hypocalcaemia, Osteoporosis.
- •Known domestic, leisure or professional exposure to elemental impurities.
- •Women who are breastfeeding or are planning to become pregnant during the study.
- •Positive pregnancy test at screening.
- •Presence of clinically significant physical, laboratory, vital signs, or ECG findings.
- •Blood lead level > 3.3 μg/dL(=33.0 μg/L) at screening.
- •galactose intolerance, fructose intolerance, Lapp lactase deficiency, sucurase-isomaltase deficiency, glucose-galactose malabsorption.
- •Receipt of any investigational agent or study drug within 4 weeks prior to screening.
- •Patients with history of alcohol or drug abuse.
- •Subjects who donated whole blood within 2 months, donated blood components within 1 month.
- •Subjects who have participated and taken investigational drug within 1 month prior to study drug administration.
- •Subjects who the investigator considers inappropriate for the study due to other reasons.
研究组 & 干预措施
DWJ1230
Experimental
干预措施: DWJ1230 (Drug)
DWB2001
Experimental
干预措施: DWB2001 (Drug)
结局指标
主要结局
To assess the concentration of lead in blood after administration of Investigational Product
时间窗: Day 7
次要结局
- To assess blood concentration of other Class IIa(Cobalt, Nickel) and of aluminium after administration of Investigational Product(Day 7)
- To assess blood concentration of other Class I(Cadmium, Arsenic, Mercury) after administration of Investigational Product(Day 7)
研究者
研究点 (1)
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