CTRI/2024/07/070710已完成不适用
A Double-Blind, Randomized, Single Dose, Two-Treatment, Two-Way Crossover, Oral Bioavailability Study Of Investigational Product Containing Vitamin C in Healthy, Adult, Human Subjects Under Fasting Conditions.
Molecules Biolab Pvt Ltd1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年7月26日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To evaluate the oral bioavailability of investigational product (500 mg capsule containing NLT 350 mg of vitamin C/ Capsule) of Molecules BioLabs Private Limited, and the reference product (500 mg capsules which contains 350 mg of conventional vitamin C) of Molecules BioLabs Private Limited in healthy, adult, human subjects under fasting conditions.
研究概览
简要总结
Vitamin C is a water-soluble vitamin that is commonly used in food. It is utilized as an additive, because of its reducing and antioxidant properties. The bioavailability and shelf life of bioactive components have both been improved by using encapsulation technology. Liposomes are vesicles that are simple models of highly complex cell membranes, consisting of lipid bilayers surrounding an aqueous core. Due to their unique biocompatibility and biodegradability, liposomes have attracted significant interest in the delivery and protection of both hydrophilic and hydrophobic compounds, such as vitamins. So liposomal encapsulated vitamin C helps to overcome the degradation of vitamin C due to high reactivity. It also improves the absorption into intestine by the controlled release of vitaminC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Normal, healthy, adult, male and female Human participants of age between 18-45 years with a Body Mass Index range between 18.50 kg/m2 to 24.99 kg/m
- •2.Subject agrees avoid vitamin C containing medications and dietary supplements from screening until last visit. 3.Subject agrees to avoid high activity physical exercise 72.00 hours prior to last visit 4.Subjects who have no evidence of underlying disease during screening and check- in and whose screening is performed within 29 days of check in. 5.Subjects generally healthy as documented at screening considered by the physician or principal orclinical investigator. 6.Healthy as documented by the 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. 7.Non- smokers or ex-smokers. Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months. 8.Willing to consume ova-lacto vegetarian diet. 9.Willing to comply to all requirements of this study protocol as well as instructed by the study personnel 10.Generally healthy as documented by gynecological examination and breast examination -for female subjects during Period-I check-in only. 11.Female subjects of childbearing potential; a.Practicing an acceptable non-hormonal contraceptive method of birth control after consulting with principal investigator; and/or b.Surgically sterile.
- •bilateral tubal ligation.
排除标准
- •1.Evidence of allergy or known hypersensitivity to Vitamin C or other related drugs or other related drugs. 2.Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse, existing tinnitus, renal or liver impairment and pre-existing gallbladder disease. 3.Any major illness in the last three months or any significant ongoing chronic medical illness. 4.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. 5.History of alcohol addiction or abuse. 6.Malabsorption syndrome that affects vitamin c metabolism. 7.Heart failure, angina pectoris, ventricular arrhythmias or atrial fibrillation with more than 100 per min ventricular rate. 8.Gastrointestinal bleeding in past three months. 9.Uncontrolled diabetes mellitus. 10.Active psychiatric disorder, intention for suicidal, disorders with Unconsciousness. 11.Psychopathic disorder, lack of cooperation. 12.Chronic obstructive lung disease or active smoking.
- •more than 2 cigarettes in the past 6 months 13.Taking more than 100 mg vitamin C daily within 2 weeks to screening. 14.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 24.00 hours prior to check-in and throughout the entire study 15.Consumption of grapefruit and its juice and poppy containing foods for at least 72.00 hours prior to check-in and throughout the study. 16.Subjects who taken any prescription medications, over the counter medicinal products, herbal medications within 14 days prior to study check in and throughout the study. 17.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. 18.An unusual or abnormal diet within 48.00 hours prior to study check-in of each period, for whatever reason e.g. because of fasting due to religious reasons. 19.Subject who had participated in any other study within the 90 days of check-in.
结局指标
主要结局
To evaluate the oral bioavailability of investigational product (500 mg capsule containing NLT 350 mg of vitamin C/ Capsule) of Molecules BioLabs Private Limited, and the reference product (500 mg capsules which contains 350 mg of conventional vitamin C) of Molecules BioLabs Private Limited in healthy, adult, human subjects under fasting conditions.
时间窗: once.
次要结局
- To monitor the adverse events and to ensure the safety of the subjects(screening and End of study.)
研究者
Dr Ambanna Gowda
Unitree Health Care Diagnostics
研究点 (1)
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