Nutrition Products - An Open-Label, Randomised, Single-Dose Study to Evaluate the Bioavailability of Omega-3 Based Dietary Supplements Under Fasting Conditions in Healthy Male and Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Area under curve of omega-3 based dietary supplements under fasted conditions.
研究概览
简要总结
The study will evaluate the bioavailability of omega-3 based dietary supplements under fasted conditions in healthy adult subjects. Each subject will participate in 5 treatment periods. The order of treatments will be in accordance with the randomisation schedule.There will be a minimum of 4 treatment-free days between each treatment period. On each dosing occasion, subjects will be fasted for at least 10 hours overnight, prior to the morning of dosing. Twenty-four subjects will be enrolled to complete dosing of 20 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •males or females
- •any ethnic origin
- •age 40 - 65 years
- •BMI 18.5 - 30.0 kg/m2
- •generally in good health
- •signed informed consent
排除标准
- •males or females not willing to use appropriate contraception
- •prescribed systemic or topical medication taken within 14 days
- •taken supplements containing omega-3 faty acids or fish oil last 14 days or any non-prescribed systemic or topical medication including herbal remedies and vitamin/mineral supplements within 7 days
- •taken any medication including St. John's Worth known to alter drug absorption within 30 days
- •subjects participating in a clinical study past 3 months
- •recent blood donation
- •significant history of drug allergy or any allergic disease
- •allergy or hypersensitivity to omega-3 fatty acids, fish, soya, oleic acid, sesame oil or other constituents of pharmaceutical preparation.
- •high consumption of tobacco
- •high consumption of alcohol
- •other significant medical history or physical findings (including HIV,hepatitis)
- •vegetarians
- •not willing to follow dietary restrictions
- •frequent migraine attacks
- •previously taken part in or withdrawn from study or according to investigator should not participate.
结局指标
主要结局
Area under curve of omega-3 based dietary supplements under fasted conditions.
时间窗: Pharmacokinetics up to 36 hours postdose
Peak plasma concentration of omega-3 based dietary supplements under fasted conditions.
时间窗: Pharmacokinetics up to 36 hours postdose
次要结局
未报告次要终点