CTRI/2025/01/079661进行中（未招募）不适用
An Open-Label, Balanced, Randomized, Single Dose, Two-Treatment, Two-Period, Two-Sequence, Two-Way Crossover Study Of Relative Bioavailability Of (T1) Actif Plus (500 Mg), (T2) Actif (500Mg) Capsules Containing Curcuminoids, In Healthy, Adult, Human Male Subjects Under Fed Conditions.
Bernd-Michael Loffler Institute for mitochondrial medicine1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年2月7日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To evaluate the relative bioavailability of (T1) Actif plus (500 mg capsule containing NLT 250 mg of curcuminoids/ capsule) of Institute for Mitochondrial Medicine, and (T2) Actif (500 mg capsules which contains 250 mg of curcuminoids) of Institute for Mitochondrial Medicine in healthy, adult, male subjects under fed conditions.
研究概览
简要总结
Curcumin is a natural compound found in turmeric, a spice commonly used in Indian cuisine and traditional medicine. It is known for its bright yellow colour and potential health benefits. Curcumin has powerful antioxidant and anti-inflammatory properties, which may help reduce inflammation in the body and protect against chronic diseases. Curcumin is a naturally occurring phytocompound extracted from the turmeric rhizome Curcuma longa, a member of the ginger (Zingiberaceae) family. However, its low bioavailability due to poor absorption and rapid elimination limits its efficacy. ACTIF Plus, a novel curcuminoids formulation using innovative technology, shows higher bioavailability, shelf life and promising therapeutic applications. So, the bioavailable form of Curcuminoids helps to overcome the degradation of Curcumin due to high reactivity. It also improves the absorption into intestine by the controlled release of Curcumin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Normal, healthy, adult, Human Male participants of age between 18-45 years with a Body Mass Index (BMI) range between 18.50 kg/m2 to 24.99 kg/m2
- •Subject agrees to avoid high activity physical exercise 72.00 hours prior to last visit
- •Subjects who have no evidence of underlying disease during screening and check- in and whose screening is performed within 21 days of check-in.
- •Subjects generally healthy considered by the physician or principal/clinical investigator to clinically, as documented by medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, musculoskeletal and central nervous systems) and vital sign assessments.
- •Non- smokers or ex-smokers.
- •Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months.
- •Willing to consume standard breakfast.
- •Willing to comply to all requirements of this study protocol as well as instructed by the study personnel
- •No consumption of Curcumin in a washout period of 14 days before the pharmacokinetic study.
排除标准
- •Evidence of allergy or known hypersensitivity to Curcumin or its inactive ingredients.
- •Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse, existing tinnitus, renal or liver impairment and pre-existing gallbladder disease.
- •Any major illness in the last three months or any significant ongoing chronic medical illness.
- •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 alcohol addiction or abuse.
- •Malabsorption syndrome that affects Curcumin metabolism.
- •Heart failure, angina pectoris, ventricular arrhythmias or atrial fibrillation with mor than 100 per min ventricular rate.
- •Gastrointestinal bleeding in the past three months.
- •Uncontrolled diabetes mellitus.
- •Active psychiatric disorder, intention for suicide, disorders with Unconsciousness.
- •Psychopathic disorder, lack of cooperation.
- •Chronic obstructive lung disease or active smoking (more than 2 cigarettes in the past 6 months)
- •Taking more than 500 mg curcumin daily within 2 weeks to screening.
- •Consumption of caffeine and /or Xanthine containing products (i.e., coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), tobacco containing products for at least 48.00 hours prior to dosing and throughout the entire study
- •Consumption of alcohol and its products, grapefruit and/or its juice and poppy containing foods for at least 72.00 hours prior to dosing and throughout the study.
- •Subjects should not take any over the counter medicinal products, herbal medications within 07 days prior to study check in and throughout the study and any prescription medications within 14 days prior to study check-in and throughout the study.
- •History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in of each period.
- •An unusual or abnormal diet within 48.00 hours prior to study dosing of each period, for whatever reason e.g., because of fasting due to religious reasons.
- •Subject who had participated in any other study within the 90 days of check-in.
- •History of difficulty in swallowing.
- •History of difficulty in accessibility of veins.
- •Positive results for alcohol breath test prior to check-in of each period
- •Any blood donation / excess blood loss within 90 days of check-in.
结局指标
主要结局
To evaluate the relative bioavailability of (T1) Actif plus (500 mg capsule containing NLT 250 mg of curcuminoids/ capsule) of Institute for Mitochondrial Medicine, and (T2) Actif (500 mg capsules which contains 250 mg of curcuminoids) of Institute for Mitochondrial Medicine in healthy, adult, male subjects under fed conditions.
时间窗: Enrollment day.
次要结局
- To monitor adverse events and to ensure the safety of the subjects.(Screening visit and End of study.)
研究者
Dr Ambanna Gowda
Unitree Health Care Diagnostics
研究点 (1)
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