NCT03327558已完成1 期
Full-replicate Study of APRISO 375 mg Extended-release Capsules Versus the Approved APRISO 375 mg Extended-release Capsules in Healthy Male and Female Subjects
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
- 60
- 试验地点
- 1
- 主要终点
- Cmax (Maximum observed plasma concentration)
研究概览
简要总结
The objective of this study is to evaluate and compare the bioavailability of mesalamine
详细描述
The objective of this study is to evaluate and compare the bioavailability of mesalamine and therefore to assess the bioequivalence of 375 mg APRISOTM extended-release capsule manufactured at a new site versus the approved 375 mg APRISOTM extended-release capsule after a single oral dose administration under fasting conditions.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female, at least 18 years of age
- •Body mass index (BMI) between18.5 and below 32.0 kg/m2 (inclusive)
- •Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, ECG and laboratory tests
排除标准
- •Any contraindication to mesalamine according to the applicable labeling
研究组 & 干预措施
Apriso 0.375G ER CAP
Experimental
Apriso 0.375G ER Cap
干预措施: Apriso 0.375G ER CAP (Drug)
APRISO 375 mg extended-release capsules
Active Comparator
APRISO 375 mg ER cap
干预措施: APRISO 375 mg extended-release capsules (Drug)
结局指标
主要结局
Cmax (Maximum observed plasma concentration)
时间窗: 3 hours after oral dose is taken
Maximum observed plasma concentration levels used for descriptive analysis
次要结局
未报告次要终点
研究者
研究点 (1)
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