NCT03443076已完成不适用
A Randomized, Crossover Study to Assess the Relative Bioavailability of Eicosapentaenoic Acid and Docosahexaenoic Acid in a Self-micro-emulsifying Delivery System (SMEDS) Formulation Compared With a Standard Omega-3-acid Ethyl Ester Product
Midwest Center for Metabolic and Cardiovascular Research4 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年2月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Baseline-adjusted, dose-normalized geometric mean ratio for SMEDS/Lovaza for EPA + DHA area under the curve (AUC) 0-24 hours
研究概览
简要总结
This study will assess the relative bioavailability of 500 mg eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) in a self-micro-emulsifying delivery system (SMEDS) formulation compared with a standard omega-3-acid ethyl ester product in healthy men and women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index 18.50-29.99 kg/m2
- •Good health on basis of medical history and routine laboratory tests
- •Score of at least 7 on vein access scale
- •Willing and able to remain at site for extended testing periods, including a total of 4 overnight stays, and to consume foods and products provided by study staff on those days
- •Willing to abstain from alcohol for 24 h prior to clinic admission
- •No plans to change smoking habits or other nicotine use
- •Willing to undergo 13 venipunctures during each treatment period
排除标准
- •Screening lab test of clinical significance
- •Positive urine drug screen
- •Clinically significant endocrine, cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, gastrointestinal or biliary disorder
- •Uncontrolled hypertension
- •Recent history or presence of cancer
- •Difficulty swallowing capsules
- •Recent blood donation or blood loss
- •Recent consumption of high-dose fish oil or fish
- •Recent use of any prescribed medication or over-the-counter medicinal products, including herbal or dietary supplements (except daily omega-3 fatty acid-free vitamin and/or mineral supplement or occasional use of acetaminophen or non-steroidal anti-inflammatory drugs)
- •Signs or symptoms of active infection or has recently taken antibiotics
- •Recent history or strong potential for drug or alcohol abuse
- •Pregnant, planning to be pregnant during the study, lactating or of childbearing potential and unwilling to commit to use of a medically approved form of contraception throughout the study (note: hormonal contraceptive use is not allowed)
结局指标
主要结局
Baseline-adjusted, dose-normalized geometric mean ratio for SMEDS/Lovaza for EPA + DHA area under the curve (AUC) 0-24 hours
时间窗: 0-24 h on Days 0-1 and on Days 14-15
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
相似试验
已完成
不适用
Bioavailability of EPA/DHA in of Ruby-O and Krill OilBioavailabilityNCT05438173Midwest Center for Metabolic and Cardiovascular Research28
已完成
2 期
Epanova® Compared to Lovaza® In a Pharmacokinetic, Single-dose, EvaluationSevere HypertriglyceridemiaNCT01208961AstraZeneca54
已完成
不适用
Study to Evaluate the Acute Bioavailability of EPA and DHA From a DietarySupplement in Healthy Men and WomenHealthyNCT02865044Calanus18
已完成
不适用
Effect of EPA and DHA in the Inflammation and Metabolic Disorders in DMD/DMB PatientsMuscular Dystrophy, DuchenneNCT01826422Coordinación de Investigación en Salud, Mexico40
已完成
不适用
Effects of Docosahexaenoic and Eicosapentaenoic Acids in Hypercholesterolemic Children Plus Diet on Docosahexaenoic Acid (DHA) StatusHypercholesterolemiaNCT00678067University of Milan36