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. - N/AP
Mr Abhijeet Morde0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
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研究设计
- 研究类型
- Ba/be
入排标准
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/m2.
- •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.
- •9.History of difficulty with donating blood or difficulty in accessibility of veins.
- •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.
- •18.Consumption of food and beverages containing xanthine (chocolates, tea, coffee or cola drinks) for at least 48.00 hours prior to check-in of study period.
- •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.
- •21.Use of macular carotenoids supplementation, omega 3 fatty acids, alpha lipoic acid or fatty acid supplements within 14 days of the start of the study.
- •22.Current use or a history of use (i.e., within 60 days of the Screening visit) of lutein and/or zeaxanthin supplements.
- •23.Positive results for alcohol breathe analysis during the check-in of study period.
- •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.
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