CTRI/2019/12/022484已完成不适用
A randomized, open label, single center, one period, single dose, three arm bioavailability study of Curcuminoid and Lutein combination based formulations in healthy human adult male subjects, under fasting conditions.
FFF Bio Works LLP1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2019年12月25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
- 9
- 试验地点
- 1
- 主要终点
- To determine the bioavailability of curcuminoids and lutein in respective Curcuminoid and Lutein combination based formulations
研究概览
简要总结
The studyconducting in healthy human male subjects to find out Curcuminoidand Lutein combination bioavailability in the body
Curcumin is the principal curcuminoid of the popular Indian spiceturmeric (Curcuma longa), which is an rhizomatous herbaceous perennial plant ofZingiberaceae family which is native to tropical South Asia.
Marigold flower (Tageteserecta L.) represents a rich source of lutein. It is grown for businesspurposes in Mexico, Peru, Ecuador, Spain, India or China. Dried Marigoldflowers contain 0.1–0.2% dry matter (DM) of carotenoids, out of which 80% arelutein diesters. By the extraction of dried and ground flowers, a non-polaroleoresin extract is acquired
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Subjects must be healthy human male subjects.
- •2.Age should be between 18-65 years of age (both inclusive), weighing at least 50 kg.
- •3.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.
- •4.Subjects with no evidence of underlying disease during the pre-study screening
- •They must be healthy as determined by medical history and physical examination and laboratory tests performed within 14 days prior to the commencement of the study.
- •6.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
- •1.Subjects who are allergic to turmeric or its extracts or curcuminoids or lutein or any food or other drugs.
- •2.Subject with resting hypotension (BP <90 /60) or hypertension (BP > 140 /90) and pulse rate below 50/min and more than 100/min.
- •3.Subject with or a prior history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, 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.
- •4.Subjects with a history of MI, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic-Impairment, Asthma, Renal Impairment, Epilepsy and Intracranial hemorrhage.
- •5.Subjects who have taken over the counter or prescribed medications including any enzyme modifying drugs within the last 14 days prior to the study.
- •6.Subject who have a History of alcoholism, drug abuse or Smoking.
- •7.Subjects who are hypersensitive to Heparin 8.Subjects who participated in any other clinical study in the past three months.
- •9.Subject with clinically significant abnormal lab values/ abnormal ECG / abnormal Chest X-ray (PA View).
- •10.Subject who has difficulty with donating blood.
- •11.Subject with history of difficulty in swallowing.
- •12.Subject who has unsuitable veins for repeated venipuncture.
结局指标
主要结局
To determine the bioavailability of curcuminoids and lutein in respective Curcuminoid and Lutein combination based formulations
时间窗: 0:00 min, 30 min, 1, 2, 3, 4, 6 and 24hrs.
次要结局
- The secondary objective of this study is to monitor the safety and tolerability of a single dose of Curcuminoid and Lutein combination formulations in healthy human adult male subjects, under fasting conditions.(0 hr to 24 hrs)
研究者
研究点 (1)
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