CTRI/2020/09/027701已完成1 期
An open-label, randomized, single-dose, two-treatment, single period, parallel oral bioavailability study of Formulated Curcumin based drink manufactured by Sipwise Beverage Pvt Ltd, Vadodara, Gujarat, India comparison with Unformulated Curcumin based drink manufactured by Sipwise Beverage Pvt Ltd, Vadodara, Gujarat, India in healthy, adult, human subjects under fed conditions.
Dr Srividhya Sundararaman0 个研究点目标入组 8 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
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •Healthy adult human volunteers of age between 18-45 years
排除标准
- •Evidence of allergy or known hypersensitivity to Curcumin and its inactive ingredients.
- •Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver
- •disease, alcohol abuse and recently overcome or active existing tinnitus.
- •Subjects with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with
- •or without coma.
- •Any major illness in the last three months or any significant ongoing chronic medical
- •Any disease or condition which might compromise the haemopoeitic, gastrointestinal,renal, hepatic, cardiovascular, musculoskeletal, respiratory, central nervous system, diabetes, psychosis or any other body system.
- •History of drug abuse within 03 months (including benzodiazepines, opioids, cocaine,
- •barbiturates, THC and amphetamine etc.)
- •History of alcohol addiction or abuse.
- •History of difficulty in swallowing.
- •History of difficulty in accessibility of veins.
- •Any blood donation / excess blood loss within 90 days of check-in.
- •Subject who had participated in any other study within the 90 days of study check-in.
- •Consumption of caffeine and /or Xanthine containing products (i.e. coffee, tea,
- •chocolate, and caffeine-containing sodas, colas, etc.) and tobacco containing products
- •for at least 24.00 hours prior to check-in and throughout the entire study.
- •Consumption of alcohol and its products, grapefruit and/ or its juice and poppy
- •containing foods within 72.00 hours prior to clinic admission and throughout the entire
- •Use of any prescribed medication within 14 days and any over the counter medicinal
- •products, herbal medications, etc. within 07 days prior to study check in and throughout
研究者
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