Pharmacokinetic in Normal Population Clinical Trial
Official title:
Effect of Fish Oil Monoglycerides on the Omega-3 Index: Pilot Study (IO3-02)
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.
Thirty-two (32) subjects will be enrolled and randomly assigned to one of the two parallel
treatment doses. The study population will be men and women of 19 years and older, with no
allergy or history of allergy to fish. Participants must not have taken omega-3 supplements
in the last 60 days prior to study enrollment. Pregnant or lactating women will be excluded
from the study.
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 of treatment, namely two (2) or three (3)
tablets per day. MaxSimil is a concentrated monoglyceride (MAG) form of omega-3 fish oil that
is better absorbed by the body compared to regular fish oil. Each capsule contains 300 mg of
monoglyceride eicosapentaenoic acid (MAG-EPA) and 130 mg of monoglyceride docosahexaenoic
acid (MAG-DHA).
Pharmacokinetics will be assessed by measuring the omega-3 index at eight (8) different times
during the study. A first blood sample will be taken before the start of treatment and then
at week four (4), eight (8), twelve (12), sixteen (16) and twenty (20). Then, two last
measurements of the omega-3 index will be done at four (4) and seven (7) weeks after the end
of treatment. The samples will all be taken by capillary puncture during visits at the
clinic. A total of nine (9) visits may be done including the recruitment/screening/enrollment
visit. Visit 1 could be done immediately after enrollment for a total of eight (8) visits
instead of nine.
The screening tasks include pregnancy testing for women, measurement of the omega-3 index,
body weight and height, recording of the baseline health status and concomitant treatment.
Then, for visits 2 to 5, study treatment will be dispensed, returned and accounted, blood
sample will be collected for the measurement of the omega-3 index, and the health status will
be followed for any adverse event outcome.
Visits 6 to 8 are post-treatment follow-ups where omega-3 index testing will be done as well
as the follow-up of the health status and concomitant medication intake.
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