CTRI/2023/10/058210尚未招募3 期
A randomized, single-dose, double-blind, 4-way crossover, 4 sequence study to assess the bioavailability of formulated Berberine (FBBN-10-23) in comparison with normal unformulated Berberine (UFBBN-10-23) supplementation in healthy volunteers. - Nil
Akay Natural Ingredients Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
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.Healthy volunteers who are not involved in any regular medication or supplementation.
- •2.Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening.
- •3.Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study.
排除标准
- •1.Subjects who have consumed Berberine containing food/supplements 2 days prior to screening.
- •2.Subjects having symptoms of viral infection.
- •3.Pregnant or lactating women.
- •4.Subjects with known hypersensitivity to the investigational products.
- •5.Subjects who have participated in any clinical trial in the past 1 month.
- •6.Any subjects found to have entered in to the study in violation of this protocol or if the subject is uncooperative during the study.
- •7.Any other condition that in the opinion of the investigator that does not justify the subject’s participation in the trial.
研究者
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