A Randomized, Open label, two arm, cross-over trial to assess the bioavailability of liposomal and non-liposomal Vitamin-C formulations in healthy volunteers.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- To determine the bioavailability of Vitamin C in liposomal and non-liposomal Vitamin C formulations in plasma by LC-MS/HPLC
研究概览
简要总结
Liposomes are spherical shells made up of a double layer of fatty acids similar to the natural layer that makes up the outer membrane of the body’s cells.†Liposomes are known to be the best inter-cell transporters because they are made of the same lipids that make up the cell membranes and hence allows lipid-soluble nutrients inside.
Liposomal Vitamin C is basically Vitamin C in a liposome. The liposomes are very small and they mimic our cells. This means that liposomal Vitamin C avoids the digestive system that usually extends the absorption process. The main differences between liposomal Vitamin C and traditional Vitamin C have got to do with their bioavailability. The traditional Vitamin C is soluble in water and therefore its bioavailability is very low. Only about 12%-14% of regular Vitamin C is absorbed when it is taken orally. However, in liposomal form, Vitamin C is being delivered directly into the cells of one’s body, without being degraded and also without consuming energy in the process, and hence maximizing the benefit
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects must be healthy human male and female (non-pregnant) subjects.
- •Age should be between 18-45 years of age (both inclusive)
- •BMI between 18.5 to 24
- •Subject who are ready to provide written informed consent and should be willing to be available throughout the study duration and should follow the guidelines mentioned in the protocol.
- •Subjects with no evidence of underlying disease during the pre-study screening.
- •They must be healthy as determined by medical history and physical examination, ECG, Chest X-ray (PA View) and laboratory tests performed within 7 days prior to the commencement of the study.
- •Subjects whose screening laboratory values are within normal limits or considered by the physician / Principal Investigator to be of no clinical significance.
排除标准
- •Subjects who are allergic to vitamin C products or any food or other drugs.
- •Subject with resting hypotension (BP less than90 /60) or hypertension (BP greterthan140 /90) and pulse rate below 50 min and more than 100/min.
- •Subject with or a prior history or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, musculoskeletal or psychiatric disease or who has been hospitalized or underwent surgery within the last 4 weeks prior to in-housing.
- •Subjects with a history of MI, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic-Impairment, Asthma, Renal Impairment, Epilepsy and Intracranial haemorrhage.
- •Subjects who have taken over the counter or prescribed medications including any enzyme modifying drugs or many vitamin supplements within the last 14 days prior to the study.
- •Subject who has a history of alcoholism, drug abuse or Smoking.
- •Subjects who are hypersensitive to Heparin
- •Subjects who participated in any other clinical study in the past three months.
- •Subject with clinically significant abnormal lab values/ abnormal ECG abnormal Chest X ray (PA View).
- •Subject who has difficulty with donating blood.
- •Subject with history of difficulty in swallowing.
结局指标
主要结局
To determine the bioavailability of Vitamin C in liposomal and non-liposomal Vitamin C formulations in plasma by LC-MS/HPLC
时间窗: Period I | Visit 1: Day 1 | Visit 2: Day 2 | Blood Sampling Point:0min, 30min, 60min, 90min, 120min, 3hrs, 4hrs, 6hrs, 8hrs, 12hrs and 24hrs. | Washout period for 5±2 days | Period II | Visit 1: Day 1 | Visit 2: Day 2
次要结局
- To monitor the safety and tolerability of a single dose of liposomal Vitamin C formulations by reviewing adverse events(Period I)
研究者
Dr Ashok Godavarthi
Radiant Research Services Pvt. Ltd