A Randomized, Open-label, Multiple Dose, Parallel Group Study to Evaluate 5 ASA and N Ac 5 ASA Pharmacokinetics Following Administration of Oral Doses of Asacol 2.4 g/Day and Lialda 2.4 g/Day for 7 Days in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Pharmacokinetic endpoints of primary interest include AUC24 and the amount of 5-ASA excreted in the urine by subjects dosed with Asacol and Lialda.
研究概览
简要总结
This study evaluated pharmacokinetics of 5-ASA and N-Ac-5-ASA associated with each of 3 regimens of oral mesalamine 2.4 g/day (Lialda 2.4 g/day 2 x 1.2 g every 24 hours, Asacol® 6 x 400 mg every 24 hours, or Asacol 2 x 400 mg every 8 hours). Primary endpoints were 5-ASA area under the plasma concentration versus time curve from zero to 24 hours (AUC24) and total 5-ASA percent of dose excreted (A'e [%]) over the 24-hour period on Day 7.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Males or females between 18 and 45 years of age, inclusive, at screening and in good general health based on medical history, physical examination, and laboratory evaluation;
- •If female, must be (as documented by patient reported medical history):
- •postmenopausal (at least 1 year without spontaneous menses), or
- •surgically sterile (tubal ligation or hysterectomy), or
- •using acceptable contraception [e.g., sexual partner with non-reversed vasectomy (with azoospermia in 2 tests), 2 barrier methods (e.g., condom, diaphragm, or spermicide), or intra-uterine device];
- •Body mass index (BMI) between 18 and 32 kg/m2, inclusive;
- •Able to swallow the assigned study medication tablet whole; and,
- •Able to fulfill the requirements of the protocol and provide written informed consent.
排除标准
- •History or presence of any condition or gastrointestinal (GI) surgery causing malabsorption or an effect on GI motility;
- •Any uncontrolled acute disease or major surgical operation requiring hospitalization within 1 month of screening;
- •History of diabetes, syncope, cardiovascular, hepatic, or renal disease;
- •Uncontrolled chronic diseases such as hypertension, systemic lupus erythematosus, or rheumatoid arthritis;
- •History of cancer within the last 5 years (except for basal cell carcinoma with a documented 6-month remission);
- •Any known enzyme-inducer, enzyme-inhibitor, or reported chronic exposure to enzyme-inducers such as paint solvents or pesticides within 30 days of treatment;
- •Any prescription drug or herbal remedy within 14 days prior to scheduled dosing
研究组 & 干预措施
1
Asacol 6x400 mg Q24h at 7 am for 7 days
干预措施: Asacol (Drug)
2
Asacol 2x400 mg Q8h at 7 am, 3 pm, and 11 pm for 7 days
干预措施: Asacol (Drug)
3
Lialda 2x1.2g Q24h at 7 am for 7 days
干预措施: Lialda (Drug)
结局指标
主要结局
Pharmacokinetic endpoints of primary interest include AUC24 and the amount of 5-ASA excreted in the urine by subjects dosed with Asacol and Lialda.
时间窗: Day 7
次要结局
未报告次要终点