A Phase 1, Randomized, Open-label, Crossover, Drug Interaction Study Evaluating the Pharmacokinetic Profiles of Sulfamethoxazole Administered Alone and in Combination With MMX® Mesalazine/Mesalamine in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration Versus Time Curve Within a Dosing Interval at Steady-State (AUCss) for Sulfamethoxazole
研究概览
简要总结
This is a drug interaction study evaluating the pharmacokinetic profiles of Sulfamethoxazole administered alone & in combination with Multi MatriX system (MMX®) formulation of mesalazine/mesalazine (Lialda®; Mesavancol®; Mezavant®) (MMX Mesalazine/mesalamine).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-55 years inclusive at the time of consent. The date of signing informed consent is defined as the beginning of the Screening Period.
- •Subject is willing to comply with any applicable contraceptive requirements of the protocol and is:
- •Non-pregnant, non-lactating female
- •Females must be at least 90 days post-partum or nulliparous.
- •Exclusion Criteria
- •A history of current or recurrent disease that could affect the colon. This includes gastrointestinal disease, peptic ulceration, gastrointestinal bleeding, celiac disease, lactose intolerance, ulcerative colitis, Crohn's disease, or Irritable Bowel Syndrome. Subjects who have a history of chronic constipation, which is physician diagnosed and treated, will also be excluded from the study (frequency of bowel movements >48 hours between samples).
- •A history of current or relevant serious, severe, or unstable (acute or progressive) physical or psychiatric illness.
- •A history of gastrointestinal surgery performed within the past 12 months prior to the first dose of investigational product, with the exception of an appendectomy.
- •A history of or current clinically relevant moderate or severe renal or hepatic impairment.
- •A history of asthma or bronchospasm associated with the use of 5-ASA or other non-steroidal anti-inflammatory drugs.
- •Known or suspected intolerance or hypersensitivity to the investigational product or sulfamethoxazole/trimethoprim, closely related compounds, or any of the stated ingredients
- •A history of, or current, pancreatitis
排除标准
- 未提供
研究组 & 干预措施
Sulfamethoxazole + MMX placebo
干预措施: sulfamethoxazole + MMX placebo (Drug)
Sulfamethoxazole + MMX Mesalazine/mesalamine
干预措施: Sulfamethoxazole + MMX Mesalazine/mesalamine (Drug)
结局指标
主要结局
Area Under the Plasma Concentration Versus Time Curve Within a Dosing Interval at Steady-State (AUCss) for Sulfamethoxazole
时间窗: Assessed over a 24-hour period starting post-dose on day 4
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure of how much and how long a drug stays in a body.
Maximum Plasma Concentration at Steady-State (Cmaxss) for Sulfamethoxazole
时间窗: Assessed over a 24-hour period starting post-dose on day 4
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
次要结局
未报告次要终点