Bioavailability of Omega-3 Food Supplements in Healthy Subjects
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Dietary Supplement: Pronovum PRF-048Dietary Supplement: Pronovum PRF-037Dietary Supplement: Pronovum PRF-047
- Registration Number
- NCT02376621
- Lead Sponsor
- Pronova BioPharma
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- males or females
- any ethnic origin
- age 40 - 65 years
- BMI 18.5 - 30.0 kg/m2
- generally in good health
- signed informed consent
Exclusion Criteria
- 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- previously taken part in or withdrawn from study or according to investigator should not participate.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PronovaPure 150:500 triglycerides Pronovum PRF-037 3 × PronovaPure 150:500 triglycerides (TG) European Union (EU) PronovaPure 150:500 triglycerides Pronovum PRF-048 3 × PronovaPure 150:500 triglycerides (TG) European Union (EU) Pronovum PRF-037 Pronovum PRF-048 3 × Pronovum PRF-037 Pronovum PRF-037 Pronovum PRF-047 3 × Pronovum PRF-037 Pronovum PRF-048 Pronovum PRF-047 3 × Pronovum PRF-048 PronovaPure 500:200 TG Pronovum PRF-047 3 × PronovaPure 500:200 TG EU Pronovum PRF-047 Pronovum PRF-047 3 × Pronovum PRF-047 Pronovum PRF-047 Pronovum PRF-037 3 × Pronovum PRF-047 PronovaPure 150:500 triglycerides Pronovum PRF-047 3 × PronovaPure 150:500 triglycerides (TG) European Union (EU) Pronovum PRF-048 Pronovum PRF-037 3 × Pronovum PRF-048 Pronovum PRF-048 Pronovum PRF-048 3 × Pronovum PRF-048 Pronovum PRF-037 Pronovum PRF-037 3 × Pronovum PRF-037 PronovaPure 500:200 TG Pronovum PRF-048 3 × PronovaPure 500:200 TG EU PronovaPure 500:200 TG Pronovum PRF-037 3 × PronovaPure 500:200 TG EU Pronovum PRF-047 Pronovum PRF-048 3 × Pronovum PRF-047
- Primary Outcome Measures
Name Time Method Area under curve of omega-3 based dietary supplements under fasted conditions. Pharmacokinetics up to 36 hours postdose Peak plasma concentration of omega-3 based dietary supplements under fasted conditions. Pharmacokinetics up to 36 hours postdose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Covance Clinical research Unit (CRU) Ltd,Springfield House, Hyde street
🇬🇧Leeds, United Kingdom