Pharmacokinetic in Normal Population Clinical Trial
Official title:
Effect of Fish Oil Monoglycerides on the Omega-3 Index: Pilot Study (IO3-02)
| Verified date | September 2019 |
| Source | SCF Pharma |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The objective of this study is to establish the pharmacokinetic curve for two different doses of MaxSimil at steady-state over a 20-week period, namely two (2) or three (3) tablets per day. MaxSimil is a concentrated fish oil monoglyceride (MAG) that facilitates absorption of the omega-3 oils by the body. Each capsule contains 300 mg of monoglyceride eicosapentaenoic acid (MAG-EPA) and 130 mg of monoglyceride docosahexaenoic acid (MAG-DHA). Thirty-two (32) subjects will be enrolled and randomly assigned to one of the two parallel treatment doses. Pharmacokinetics will be assessed by measuring the omega-3 index at eight (8) different times during the study. A first sample will be taken before the start of treatment and then every four (4) weeks during treatment. Then, two last measurements of the omega-3 index will be done at four (4) and seven (7) weeks after the end of treatment. Apart from the study treatment and collection of samples for the measurement of the omega-3 index, the only other interventions will be the measurement of body weight at screening and at the end of the study, pregnancy test for women at screening, questioning for demographic information and for the follow-up of the subject's health and concomitant medication intake.
| Status | Completed |
| Enrollment | 32 |
| Est. completion date | August 9, 2019 |
| Est. primary completion date | August 9, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 19 Years and older |
| Eligibility |
Inclusion Criteria: 1. Participant of at least 19 years old. 2. Available for the entire duration of the study and willing to participate based on the information provided in the informed consent form (ICF) duly read and signed by the latter. 3. Absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements, ability to cooperate adequately, to understand and observe the instructions of the coordinator of the study. 4. Participant having no difficulty swallowing tablets or capsules. Exclusion Criteria: 1. Known allergy to fish or history of allergic reactions attributable to fish, or a compound similar to fish oil. 2. Females who are pregnant or lactating, or has tested positive to a pregnancy test at screening. 3. Participant who used omega-3 supplements within 60 days prior to Day 1 of the study. 4. Participant who, in the opinion of the research coordinator, may not be able to comply with the requirements of the protocol |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Clinique Gestion Santé de la Baie | Maria | Quebec |
| Canada | Clinique GSM du Littoral | Pointe-au-Père | Quebec |
| Lead Sponsor | Collaborator |
|---|---|
| Samuel Fortin |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Measurement of the Omega-3 index over time to establish the Pharmacokinetic curve and bioavailability at steady state. | The objective of this pilot study is to collect preliminary bioavailability data for two different daily doses of MaxSimil at steady-state, that to say 600mg/260mg and 900mg/490mg daily of EPA/DHA. Blood samples will be taken by capillary puncture at specific time points during treatment and will be analysed to establish the omega-3 index (the fraction of EPA + DHA in the total fatty acids contained in red blood cells) which serves as bioavailability marker. | 12 months |