Pharmacodynamic Evaluation of Stool Output Following Oral Administration of Various Low Volume PEG3350-based Gut Cleansing Solutions Using the Split Dose Intake in Healthy Subjects (OUT)
2013年4月15日 更新者:Norgine
This study is to investigate the effect of various modified low volume polyethylene glycol (PEG) 3350 and ascorbic acid/ascorbate (PEG+ASC)-based gut cleansing solutions on stool output in healthy subjects.
In addition, the study is to assess and compare the safety and tolerance of the modified PEG+ASC formulations following oral administration with the safety profile of MOVIPREP®.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
161
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Timisoara、罗马尼亚、300244
- Pierrel Research HP-RO-SRL
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Timisoara、罗马尼亚
- Pierrel Research HP-RO-SRL
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 45年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- The subject's written informed consent must be obtained prior to inclusion.
- Healthy subjects with an age of 18 to 45 years.
- Healthy subjects need to be without any history of clinical significant gastrointestinal symptoms by clinical judgement and without the presence of acute abdominal discomfort or symptoms.
- Females must be surgically sterile, practicing true sexual abstinence or using an acceptable form of effective contraception throughout the study from the following list: contraceptive implants, injectables, oral contraceptives, intrauterine system (IUS), some intrauterine devices (IUDs), vasectomised partner or barrier method (condom or occlusive cap) with spermicidal foam/gel/film/cream/suppository. Hormonal and IUD methods of contraception must be established for a period of 3 months prior to dosing and cannot be changed or altered during the study. All females must have a negative pregnancy test at screening and check-in.
- Willing, able and competent to complete the entire procedure and to comply with study instructions.
Exclusion Criteria:
- Use of laxatives in the last 12 months or colon motility altering drugs in the last 6 months.
- Use of any prescription or over-the-counter (OTC) medication within 4 weeks prior to the first dose of investigational drug (excluding hormonal contraception, and occasional use of nonsteroidal anti-inflammatory drugs [NSAID], acetaminophen or metamizole).
- Donation or loss of 500 mL or more of blood within 8 weeks prior to the first dose of investigational drug.
- Any evidence of the history or presence of organic or functional gastrointestinal conditions (e.g. chronic constipation, irritable bowel syndrome [IBS], inflammatory bowel disease [IBD]).
- Exhibiting relevant abnormal gastrointestinal motility according to clinical judgement in the past or now.
- History or presence of any clinically significant acute illness within the 4 weeks prior to the first dose of investigational drug based on clinical judgement at screening and check-in evaluation.
- Known glucose-6-phosphatase dehydrogenase deficiency.
- Known phenylketonuria.
- History or evidence of any clinical significant systemic cardiovascular, hepatic, pulmonal, neurological, metabolic and/or renal organ dysfunction.
- History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis), known hypersensitivity to polyethylene glycols and/or ascorbic acid.
- History or evidence of any clinically relevant electrocardiogram (ECG) abnormalities and hypertension.
- Evidence of dehydration.
- Any evidence for abnormal sodium or potassium levels or clinically significant other electrolyte disturbances.
- Females who are pregnant, having a positive pregnancy test at screening and/or admission to unit or planning a pregnancy. Females not using reliable methods of birth control.
- Clinically relevant findings on physical examination based on Investigator's judgement.
- Clinically relevant deviations of laboratory parameters from reference ranges at screening or check-in evaluation.
- Positive serology for chronic viral hepatitis or human immunodeficiency virus (HIV) at screening.
- History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or check-in evaluations.
- Subjects who are unwilling to comply with the provisions of the study protocol.
- Concurrent participation in an investigational drug study or participation within 3 month of study entry.
- Subject has a condition or is in a situation, which in the Investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly.
- Previous participation in the study.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Part A, arm 1
Evening dose 1 plus fixed morning dose
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Single evening dose of 750mL solution containing 100g PEG3350 plus 6g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose of 750mL solution containing 100g PEG3350 plus 9g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose of 750mL solution containing 75g PEG3350 plus 5.6g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350 and 56.6g sodium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate and 21.4g magnesium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350, 6g sodium sulphate and 33.9g sodium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 29g PEG3350 and 4.8g sulphate and 23.3g ascorbic acid.
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实验性的:Part A, arm 2
Evening dose 2 plus fixed morninf does
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Single evening dose of 750mL solution containing 100g PEG3350 plus 6g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose of 750mL solution containing 100g PEG3350 plus 9g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose of 750mL solution containing 75g PEG3350 plus 5.6g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350 and 56.6g sodium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate and 21.4g magnesium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350, 6g sodium sulphate and 33.9g sodium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 29g PEG3350 and 4.8g sulphate and 23.3g ascorbic acid.
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实验性的:Part A, arm 3
Evening dose 3 plus fixed morning dose
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Single evening dose of 750mL solution containing 100g PEG3350 plus 6g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose of 750mL solution containing 100g PEG3350 plus 9g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose of 750mL solution containing 75g PEG3350 plus 5.6g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350 and 56.6g sodium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate and 21.4g magnesium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350, 6g sodium sulphate and 33.9g sodium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 29g PEG3350 and 4.8g sulphate and 23.3g ascorbic acid.
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有源比较器:Part A, arm 4
Moviprep
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Reconstituted and administered in accordance with recommended split dose intake: one litre in the evening, one litre the following morning.
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实验性的:Part B, arm 1
Fixed evening dose plus morning dose 1
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Single evening dose of 750mL solution containing 100g PEG3350 plus 6g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose of 750mL solution containing 100g PEG3350 plus 9g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose of 750mL solution containing 75g PEG3350 plus 5.6g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350 and 56.6g sodium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate and 21.4g magnesium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350, 6g sodium sulphate and 33.9g sodium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 29g PEG3350 and 4.8g sulphate and 23.3g ascorbic acid.
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实验性的:Part B, arm 2
Fixed evening dose plus morning dose 2
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Single evening dose of 750mL solution containing 100g PEG3350 plus 6g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose of 750mL solution containing 100g PEG3350 plus 9g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose of 750mL solution containing 75g PEG3350 plus 5.6g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350 and 56.6g sodium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate and 21.4g magnesium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350, 6g sodium sulphate and 33.9g sodium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 29g PEG3350 and 4.8g sulphate and 23.3g ascorbic acid.
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实验性的:Part B, arm 3
Fixed evening dose plus morning dose 3
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Single evening dose of 750mL solution containing 100g PEG3350 plus 6g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose of 750mL solution containing 100g PEG3350 plus 9g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose of 750mL solution containing 75g PEG3350 plus 5.6g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350 and 56.6g sodium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate and 21.4g magnesium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350, 6g sodium sulphate and 33.9g sodium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 29g PEG3350 and 4.8g sulphate and 23.3g ascorbic acid.
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实验性的:Part B, arm 4
Fixed evening dose plus alternative morning dose
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Single evening dose of 750mL solution containing 100g PEG3350 plus 6g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose of 750mL solution containing 100g PEG3350 plus 9g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose of 750mL solution containing 75g PEG3350 plus 5.6g sodium sulphate.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350 and 56.6g sodium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate and 21.4g magnesium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 40g PEG3350, 6g sodium sulphate and 33.9g sodium ascorbate.
Single evening dose containing formulation selected from Part A of study.
Single morning dose containing 29g PEG3350 and 4.8g sulphate and 23.3g ascorbic acid.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Primary Variable
大体时间:36 Hours
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Stool weight output generated from the start of intake for the following 24 hours.
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36 Hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
PEG3350 concentration
大体时间:96 Hours
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Concentration of PEG3350 in blood, urine and faeces.
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96 Hours
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Sulphate concentration
大体时间:96 hours
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Concentration of PEG3350 in blood, urine and faeces.
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96 hours
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Ascorbic acid concentration
大体时间:96 hours
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Concentration of ascorbic acid in blood, urine and faeces.
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96 hours
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Electrolytes concentration
大体时间:96 hours
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Concentration of electrolytes in blood, urine and faeces.
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96 hours
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Safety profile
大体时间:96 hours
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Spontaneouly reported adverse events will be recorded throughout the study
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96 hours
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年4月1日
初级完成 (实际的)
2011年9月1日
研究完成 (实际的)
2011年12月1日
研究注册日期
首次提交
2013年4月15日
首先提交符合 QC 标准的
2013年4月15日
首次发布 (估计)
2013年4月18日
研究记录更新
最后更新发布 (估计)
2013年4月18日
上次提交的符合 QC 标准的更新
2013年4月15日
最后验证
2013年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
NER1006的临床试验
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Norgine完全的
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