2025-521598-16-00招募中4 期
A double blinded, balanced, randomized, two-treatment, four-period, two-sequence, single-dose, crossover fully replicate bioequivalence study comparing Mesalamine Delayed Release Tablets USP 1.2 g manufactured by Sun Pharmaceutical Industries Limited, India with Mezavant (mesalamine) Delayed and Extended-Release Tablets 1.2 g product of Takeda Canada Inc., in healthy, adult, human subjects under fed condition.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 1
研究概览
简要总结
暂无简介。
入排标准
- 年龄范围
- 18 years 至 64 years(18-64 Years)
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究者
Arshad Khuroo
Scientific
Sun Pharmaceutical Industries Limited
研究点 (1)
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