Pronovum - An Open-label, Randomized, Single-dose Study to Evaluate the Bioavailability of Omega-3 Food Supplements 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
- 1
- 主要终点
- Peak plasma concentration of omega-3 food supplements under light fed conditions in healthy subjects.
研究概览
简要总结
The study will evaluate the relative bioavailability of Pronovum PRF-037 and Pronovum PRF-041 with PronovaPure 150:150 EE EU and Eskimo-3 (500 mg omega-3 acid triglyceride containing 80 mg EPA and 50 mg DHA per gram oil) in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 接受健康志愿者
- 是
入选标准
- •males or females
- •any ethnic origin
- •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 within 14 days and slow release medication considered to be active within 14 days.
- •omega-3 fatty acids or fish oil within 2 weeks of dosing.
- •any non-prescribed systemic or topical medication including herbal remedies and vitamin/mineral supplements within 7 days
- •any medication incl. St.John's Worth known to chronically alter drug absorption/elimination within 30 days
- •Subjects still present in clinical study or in the past 3 months
- •recent blood donation
- •drug allergy or significant allergic disease
- •allergic or hypersensitivity to omega-3 acids, fish, soya, oleic acid, sesame oil or other constituents in pharma preparation
- •high consumption of alcohol
- •high consumption of tobacco
- •hepatitis or HIV
- •vegetarians
- •earlier participated in or withdrawn from the study
- •not willing to follow dietary restrictions
- •frequent occurence of migraine attacks
- •subjects that should not participate according to investigator
研究组 & 干预措施
Pronova Pure 150:500 EE EU
2 × PronovaPure 150:500 EE EU
干预措施: Pronova Pure 150:500 EE EU (Dietary Supplement)
Pronova Pure 150:500 EE EU
2 × PronovaPure 150:500 EE EU
干预措施: Pronovum PRF-037 (Dietary Supplement)
Pronova Pure 150:500 EE EU
2 × PronovaPure 150:500 EE EU
干预措施: Pronovum PRF-041 (Dietary Supplement)
Pronova Pure 150:500 EE EU
2 × PronovaPure 150:500 EE EU
干预措施: Eskimo-3 (Dietary Supplement)
Pronovum PRF-037
2 × Pronovum PRF-037
干预措施: Pronova Pure 150:500 EE EU (Dietary Supplement)
Pronovum PRF-037
2 × Pronovum PRF-037
干预措施: Pronovum PRF-037 (Dietary Supplement)
Pronovum PRF-037
2 × Pronovum PRF-037
干预措施: Pronovum PRF-041 (Dietary Supplement)
Pronovum PRF-037
2 × Pronovum PRF-037
干预措施: Eskimo-3 (Dietary Supplement)
Pronovum PRF-041
2 × Pronovum PRF-041
干预措施: Pronova Pure 150:500 EE EU (Dietary Supplement)
Pronovum PRF-041
2 × Pronovum PRF-041
干预措施: Pronovum PRF-037 (Dietary Supplement)
Pronovum PRF-041
2 × Pronovum PRF-041
干预措施: Pronovum PRF-041 (Dietary Supplement)
Pronovum PRF-041
2 × Pronovum PRF-041
干预措施: Eskimo-3 (Dietary Supplement)
Eskimo-3
3 × Eskimo-3
干预措施: Pronova Pure 150:500 EE EU (Dietary Supplement)
Eskimo-3
3 × Eskimo-3
干预措施: Pronovum PRF-037 (Dietary Supplement)
Eskimo-3
3 × Eskimo-3
干预措施: Pronovum PRF-041 (Dietary Supplement)
Eskimo-3
3 × Eskimo-3
干预措施: Eskimo-3 (Dietary Supplement)
结局指标
主要结局
Peak plasma concentration of omega-3 food supplements under light fed conditions in healthy subjects.
时间窗: Pharmacikinetics up to 36 hours post-dose
Area under curve of omega-3 food supplements under light fed conditions in healthy subjects.
时间窗: Pharmacikinetics up to 36 hours post-dose
次要结局
- Number of participants with adverse events as a measure of safety and tolerability.(During entire study period, an expected average of 7 weeks from screening to last visit.)