ACTRN12620000836932已完成未知
A study to evaluate the plasma absorption of 4 (four) EPA/DHA formulations on increasingOmega-3 fatty acid concentration in healthy participants over an 8-week period.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 77
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •Men and women aged over 18 years with normal dietary habits (no medically prescribed diet or slimming diet)
- •- No history or evidence of clinically significant medical conditions including, but not limited to, cardiovascular, neurological, psychiatric, renal, immunological, endocrine (including
- •uncontrolled diabetes or thyroid disease) or haemotogical abnormalities that are uncontrolled.
- •- Participant’s full agreement and ability to consent to participation in the study
- •- Participant’s ability to participate fully and comply with demands of the study including
- •attendance at all scheduled blood collection time points.
排除标准
- •- Allergy to fish or shellfish
- •- Previous history of hematologic diseases (eg, known susceptibility to thrombosis)
- •- Concomitant use of anticoagulant drugs (eg Warfarin Sodium) and any other prescribed
- •medication except for females on the oral contraceptive pill
- •- Female participants currently pregnant or undergoing fertility treatment
- •- Regular use of supplements containing omega-3 fatty acids, regular consumption of foods
- •supplemented with omega-3 fatty acids such as some breads and milk products, consumption of fish as part of regular dietary patterns, high alcohol consumption (greater than 21 standard drinks/week)
- •- Reported participation in another omega-3 trial within 1 month before the start of the study
- •- Recent history (within 12 months) of substance abuse including alcohol
- •- Development of serious, adverse events/reactions including but not limited to; fainting, life threatening dehydration and/or serious bruising from blood sampling, excessive and prolonged
- •diarrhoea or gastrointestinal upset from fish oil consumption.
- •- Received treatment (radio &/or chemotherapy) for cancer (excluding SCC or BCC skin
- •cancer) in past 2 years.
- •- Current smoker.
研究者
相似试验
已完成
不适用
A phase 1 study to investigate the absorption, metabolism and excretion of [14C] AT1001 (migalastat hydrochloride) following a single oral administration in healthy volunteers.NL-OMON35820Amicus Therapeutics, Inc.6
已完成
不适用
A Phase 1 study to investigate the absorption, metabolism and excretion of 14C-Orteronel (TAK-700) following a single oral administration in healthy subjects10036958Prostate cancerNL-OMON36117Millenium Pharmaceuticals6
已完成
1 期
A study to see how [14C]-S-033188 is taken up, broken down and removed from the bodyRespiratoryInfluenza, virus not identifiedInfluenza virus infectionISRCTN74587134Shionogi Ltd6
已完成
不适用
A phase 1 study to evaluate the absorption, metabolism and excretion of BCX7353 following administration of a single, oral dose of [14C]-radiolabeled BCX7353 to healthy male subjects.NL-OMON44289BioCryst Pharmaceuticals, Inc.7
已完成
1 期
Mass Balance Study of [14C]-S-600918 Oral Suspension in Healthy Male SubjectsHealthy subjectsJPRN-jRCT1080225285Shionogi B.V.6
