CTRI/2018/08/015403尚未招募1 期
A double blind, balanced, randomized, two-treatment, single-period, single-dose, parallel, bioavailability/bioequivalence study of Lutein formulations - Product C and Product D (Lutein 20 mg/capsule) supplementation in healthy, adult human subjects under fed conditions.
Mr Abhijeet Morde1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年8月21日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare the bioavailability/ bioequivalence of lutein from a single oral dose of lutein formulations - Product C and Product D (Lutein 20 mg/ capsule) supplementation in healthy, adult human subjects under fed conditions.
研究概览
简要总结
This is a double blind, balanced,randomized, two-treatment, single-period, single-dose, parallel, comparativebioavailability study of Lutein formulations - Product C and Product D (Lutein 20mg/capsule) supplementation in healthy, adult human subjects under fedconditions.
Each subject enrolled willparticipate in single period study in accordance with the randomisationschedule, as per the randomization schedule, under fed conditions and subjectswill be dosed in parallel manner either Product (C) or Product (D) ‘treatment’in the single period.
Asit is a single-period, parallel design, washout period is not applicable forthis study. The total clinical duration of the study is approximately 07 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy, adult, human subjects within the age range of ≥ 21 to 55 years.
- •2.A body mass index between 20 to 27 kg/m
- •3.Participation is truly voluntary.
- •4.Subjects should avoid lutein and zeaxanthin-Yellow and green rich vegetables and fruits such as mangoes, tangerines, oranges, asparagus, broccoli, butternut squash, cilantro, collards, orange pepper, parsley, papaya, peas, pistachio, romaine lettuce, scallions, zucchini, kale, Brassica oleracea, spinach, carrots, corn, tomatoes, nectarines, and peaches etc.
- •during the study period and restricted to ≤1-2 servings per day at least for a week before dosing 5.Subjects should exclude eggs from diet during the period of the study.
- •6.Non-smokers and non-alcoholics.
- •7.Given written informed consent to participate in the study.
- •8.Absence of disease markers of HIV 1 & 2, hepatitis B & C virus.
- •9.Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history, physical examination and systemic examination during the screening.
- •10.A normal 12-lead ECG.
- •11.A normal chest X-ray (PA view) done within past 6 months.
- •12.Compliance with the requirement of the entire protocol.
- •13.For female subjects: •Female of childbearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence: or •Postmenopausal for at least 1 year, or •Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the subject).
排除标准
- •1.Institutionalized subjects.
- •2.History or evidence of hypersensitive to Lutein or Zeaxanthin.
- •3.History or evidence of chronic diseases such as diabetes, hypertension, liver disorders, kidney disorders, pulmonary disease or infections, cardiovascular disease, pancreatic disease, infectious diseases, dermatological problems, arthritis and any cancer.
- •4.History of hypo and hyperthyroidism.
- •5.Presence of alarm signs or symptoms, including fever, gastrointestinal bleeding, unintentional weight loss, anemia, dysphagia, or abdominal mass.
- •6.History of milk, gluten allergies or other known food intolerances and or any food allergies.
- •7.History of significant systemic diseases, seizures, psychiatric disorders, neurological disorders, depression, or mental illness and allergic rash.
- •8.Habit of consuming high caffeine (more than 5 cups of coffee or tea/day) consumption.
- •10.History of addiction to any recreational drug or drug dependence.
- •11.Donation of blood (one unit or 350 mL) within 90 days prior to study check-in.
- •12.Participation in any clinical study within the past 90 days.
- •13.Receipt of any prescription drugs or over-the-counter drugs (e.g.: cold preparations antacid preparations and natural products used for therapeutic benefits) within 30 days prior to screening.
- •14.Current use of vitamin or multivitamin supplements providing carotenoids (e.g., supplements including lutein, beta-carotene, lycopene, or beta-cryptoxanthin).
- •15.History of dehydration from diarrhea, vomiting or any other reason within a period of 24.0 hours prior to check-in of study period.
- •16.An unusual or abnormal diet within 48.00 hours prior to check-in of study period, for whatever reason e.g. because of fasting due to religious reasons.
- •17.Received pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 14 days of the start of the study.
- •19.Consumed grapefruit and grapefruit like citrus fruit (mosumbi/sweet lime) or juice within the 7 days prior to check-in of study period.
- •20.Positive results for drugs of abuse (benzodiazepines, opioids, amphetamines, cannabinoids, cocaines and barbiturates) in urine during the check-in of study period.
- •22.Current use or a history of use (i.e., within 60 days of the Screening visit) of lutein and/or zeaxanthin supplements.
- •24.Female volunteers demonstrating positive pregnancy test.
- •25.Female volunteers who are currently breast-feeding or who are likely to become pregnant during the study.
- •26.Female volunteers who have used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 30 days before dosing.
结局指标
主要结局
To compare the bioavailability/ bioequivalence of lutein from a single oral dose of lutein formulations - Product C and Product D (Lutein 20 mg/ capsule) supplementation in healthy, adult human subjects under fed conditions.
时间窗: Fourteen (14) blood samples of 1 x 6 mL will be collected in pre-labelled plain vacutainer during study. | Three pre-dose blood samples at -48.00, -24.00 hours [with a window period of ± 30 minutes) and 0.00 hours (within 45 minutes before dosing) will be collected before dosing. | Single venous blood sample will be withdrawn at 2.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 20.00, 24.00, 48.00 and 72.00 hours post-dose on day 0
次要结局
- The following parameters will be determined from the serum baseline corrected and baseline-uncorrected Lutein data using Phoenix WinNonlin 6.4 or higher version.(Primary parameters: Cmax and AUC0-72h)
研究者
研究点 (1)
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