CTRI/2022/08/044582已完成未知
An open-label, balanced, randomized, single oral dose, two treatment, two-period, two-sequence, two way crossover, bioavailability study of Narpega oral liquid 40 ML (each 10 ml contains at least 900mg of ethyl esters of omega-3 fatty acids and quercetin 14mg) of KMS Health Center Pvt. Ltd. and LOVAZA® 4 x 1 gram capsule (each 1gm capsule contains at least 900mg of the ethyl esters of omega-3 fatty acids) of GlaxoSmithKline (Woodward Pharma) along with 1 Capsule of Quercetin capsule 56mg of KMS Health Center Pvt. Ltd., in healthy, adult, human subjects under fasting conditions. - OMEG-3736-22
KMS Health center pvt ltd0 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
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1.Healthy, adult, human volunteers of age 18- 45 years with a minimum weight of 55 kg for male and 50 Kg for female with a Body Mass Index (BMI) ranges between 18.50 kg/m2 to 24.90 kg/m2.
- •2.Subjects with Hemoglobin >= 12g/dl for male and >= 11g/dl for female.
- •3.Given written informed consent to participate in the study.
- •4.Willing to comply with all the requirements of this study protocol.
- •5.Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 21 days of check in.
- •6.Subjects whose screening laboratory values are within normal limits or considered by the physician or Principal/Clinical Investigator to be of no clinical significance (laboratory tests are presented in Annexure-IV).
- •7.Generally 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.
- •8.Generally healthy as documented by 12-lead electrocardiogram (ECG), X-Ray and clinical laboratory assessments.
- •9.Non- smokers, non-alcoholics.
- •10.Subjects with normal limits or clinically non-significant laboratory evaluation results for follicle stimulating hormone (FSH) and luteinizing hormone (LH).
- •11.Female subjects of childbearing potential who;
- •12.Practice an acceptable non-hormonal contraceptive method of birth control after consulting with principal investigator; and/or
- •13.Surgically sterile (bilateral tubal ligation).
排除标准
- •1.Has a history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal (GI), endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- •2.Any major illness in the last three months or any significant ongoing chronic medical illness.
- •3.Has used fish oil, other EPA and/or DHA containing supplements within 3 weeks of check-in.
- •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.
- •6.History of Consumption of caffeine and /or xanthine products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) and tobacco containing products for at least 24.00 hours prior to check-in and throughout the study.
- •7.History of Consumption of grapefruit and/or its juice and poppy containing foods for at least 72.00 hours prior to check-in and throughout the study.
- •8.Subject who had participated in any other study within the 90 days of check-in.
- •9.History of difficulty in swallowing.
- •10.Any blood donation / excess blood loss within 90 days of check-in.
- •11.Severe hepatic dysfunction.
- •12.Patients with hereditary disease such as galactose intolerance, lactase deficiency, glucose-galactose malabsorption
- •13.Female subjects demonstrating a positive pregnancy screen.
- •14.Female subjects who are currently lactating.
- •15.Use of hormone replacement therapy within 06 months prior to check-in.
- •16.Female subjects with child bearing potential using prohibited contraceptive method (oral, injectable or implantable hormonal agents).
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