CTRI/2022/09/045647已完成1 期
A Single arm, Open label, Single dose and Multiple dose Study to evaluate Pharmacokinetics, Safety & Tolerability of 101-PGC-005 in Healthy, Adult, Human subjects.
AXAI LIFE SCIENCES PVT LTD0 个研究点目标入组 6 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1 Able to comprehend the nature and purpose of the study and willing to give audio-visual & written informed consent for participation in the study.
- •2 Willing to be available for the entire study period and to comply with protocol requirements.
- •3 Normal, healthy, adult, human subject of 18-45 years (both inclusive) of age.
- •4 Body mass index in the range of 18 â?? 30 kg/m2 (both inclusive).
排除标准
- •1 Has consumed dexamethasone or any other corticosteroid oral or intravenous for any reasons in past 4 weeks before study entry.
- •2 Use of any Investigational vaccine within the last three years except for Covid-19 vaccines.
- •3 Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or bloodâ??forming organs.
- •4 History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
研究者
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