Comparing the Pharmacological Profile of Enteric Coated and Non-Enteric Coated Capsules Containing Omega 3 Fatty Acids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- AUC: the area under the concentration-time curve
研究概览
简要总结
The primary objective of this study is to investigate the uptake/gastrointestinal absorption of fatty acids in healthy adult volunteers by using enteric coated and non-enteric coated soft capsules containing omega 3 fatty acids. Pharmacokinetic parameters such as AUC and Cmax, as well as any adverse events are recorded.
As secondary objective, the short-term effects of Omega-3 supplementation on blood lipid parameters in healthy volunteers are evaluated using a Cholestech LDX analyzer to measure cholesterol and related lipids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 21-65
- •healthy, good physical condition
排除标准
- •Pregnancy or breast-feeding
- •Gastrointestinal conditions
- •Acute or chronic liver disease
- •Acute or chronic kidney disease
- •Acute or chronic cardiovascular disease
- •Allergy or Intolerance to gluten
- •Allergy or Intolerance to fish or shellfish
- •Use of medications (e.g., anticoagulants/ blood thinners such as warfarin; blood lipid-lowering agents such as statins)
- •Use of Fish oil supplements
- •Use of any form of nicotine or tobacco
- •Alcohol and substance abuse history
- •Participation in another investigational study
结局指标
主要结局
AUC: the area under the concentration-time curve
时间窗: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
To determine the gastrointestinal absorption of orally ingested omega-3 fatty acids in enteric coated soft gel capsules in healthy adult volunteers and compare the Area under the plasma concentration versus time curve (AUC) with that of non-enteric coated soft capsules containing omega 3 fatty acids.
Cmax: maximum plasma concentration
时间窗: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
To determine the gastrointestinal absorption of orally ingested omega-3 fatty acids in enteric coated soft gel capsules in healthy adult volunteers and compare the Peak Plasma Concentration (Cmax) with that of non-enteric coated soft capsules containing omega 3 fatty acids.
Tmax: the time point of maximum plasma concentration
时间窗: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
To determine the gastrointestinal absorption of orally ingested omega-3 fatty acids in enteric coated soft gel capsules in healthy adult volunteers and compare the time point of maximum plasma concentration (Tmax) with that of non-enteric coated soft capsules containing omega 3 fatty acids.
次要结局
- Changes in blood lipid concentrations(0 (Baseline; pre-dose), 3, 6, 12, 24, 48, 72, 96, 120 hours post-dose)
- Effects on blood lipid parameters(0 (Baseline; pre-dose), 3, 6, 12, 24, 48, 72, 96, 120 hours post-dose)