2023-509484-24-00已完成4 期
A pivotal, randomized, open-label, two-treatment, two-sequence, four periods, crossover clinical trial to evaluate the bioequivalence of single doses of Test product Sacubitril/Valsartan, film-coated tablets 97 mg/103 mg (Manufacturer: JSC «Farmak», Ukraine) and Reference Entresto®, film-coated tablets 97 mg/103 mg (Novartis Europharm Limited, Ireland) in healthy subjects under fasted conditions
Farmak JSC1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年5月6日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 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
Olena Barbukho
Scientific
Farmak JSC
研究点 (1)
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