NCT00622375已完成1 期
A Phase I, Single- And Multiple-Dose, Relative Bioavailability and Pharmacokinetic Study of Encapsulated Mesalamine Granules Administered Orally to Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Individual pharmacokinetic parameters for mesalamine and its metabolites will be summarized with descriptive statistics
研究概览
简要总结
The current study is being conducted to evaluate the relative bioavailability and single- and multiple-dose pharmacokinetics of encapsulated mesalamine granules(eMG) in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject is Male, or female of Non-childbearing potentia.l
- •The subject is female of childbearing potential, who has a negative serum pregnancy test at screen and agrees to using appropriate birth control.
- •The subject is between the ages of 18 and 45 years.
- •The subject has a body mass index (BMI) between 18 and 32 kg/m2 (weight/[height]).
排除标准
- •The subject is seropositive for human immunodeficiency virus (HIV),hepatitis B surface antigen, and/or hepatitis C virus.
- •The subject has any clinically significant medical, social, or emotional problem.
- •The subject is pregnant or lactating
- •The subject has a history of clinically significant renal, hepatic,endocrine, oncological,gastrointestinal, or cardiovascular disease or a history of epilepsy, asthma, diabetes mellitus, psychosis, glaucoma, or severe head injury.
- •The subject is currently receiving mesalamine or aspirin containing products
- •The subject has a history of viral, bacterial, or fungal infection within 4 weeks of screening.
- •The subject has an acute illness within 1 week of study-drug administration.
- •The subject has an abnormal nutritional status, including unconventional, alternative,and abnormal diets; excessive or unusual vitamin intake; malabsorption; psychological eating disorders; difficulty swallowing medication; significant recent weight change; etc.
- •The subject has clinically significant allergies.
- •The subject has a hypersensitivity or allergy to mesalamine or other salicylate.
- •The subject has known or suspected alcohol abuse or illicit drug use within the past year
- •The subject has used tobacco (or nicotine products) during the 6 months prior to screening
- •The subject has participated in an investigational drug study within the 30 days before receiving study drug
研究组 & 干预措施
1
Experimental
干预措施: mesalamine (Drug)
结局指标
主要结局
Individual pharmacokinetic parameters for mesalamine and its metabolites will be summarized with descriptive statistics
时间窗: 14 days
次要结局
未报告次要终点
研究者
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