This study is a randomized, open-label, cross-over study in healthy subjects performed at a
single study center. The study is divided into two parts, Part 1 and Part 2. The purpose of
the study is to compare the pharmacokinetics (PK) of three different prototype capsule
formulations (omega-3-carboxylic acids test formulations) with Epanova® capsules 1000 mg
under fasted conditions in Part 1 and under fed conditions in Part 2. The results will be
used as basis for choice of formulation for further pharmaceutical development.
To assess the relative bioavailability of the different omega-3-carboxylic acids prototype
capsule formulations in relation to Epanova® capsules 1000 mg under fed and fasted
- Provision of signed and dated written informed consent prior to any study specific
- Healthy male and female (non-childbearing potential) subjects aged 18 to 55 years
with suitable veins for cannulation or repeated venipuncture.
- Females must have a negative pregnancy test at screening and on admission to the
clinical unit, must not be lactating and must be of non-childbearing potential,
confirmed at screening by fulfilling one of the following criteria:
- Post-menopausal, defined as amenorrhea for at least 12 months or more following
cessation of all exogenous hormonal treatments, and follicle-stimulating hormone
(FSH) levels in the post-menopausal range.
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral
oophorectomy or bilateral salpingectomy or tubal ligation.
- Have a body mass index (BMI) between 18.5 and 29.9 kg/m2 inclusive and weigh at least
50 kg and no more than 100 kg inclusive.
- History of any clinically significant disease or disorder which, in the opinion of
the investigator, may either put the potential subject at risk because of
participation in the study, or influences the results or the potential subject's
ability to participate in the study.
- History or presence of gastrointestinal, hepatic or renal disease, or any other
condition known to interfere with absorption, distribution, metabolism, or excretion
- Current smokers or those who have smoked or used nicotine products within the
previous 3 months.
- Consumption of poppy seeds within 7 days of first administration of IMP.
- Consumption of fish within 7 days prior to admission to the clinical unit.
- Used fish oil, other omega-3 fatty acids (EPA and/or DHA) containing supplements
within 1 month of admission to the clinical unit.
- Have a known sensitivity or allergy to soybeans, fish and/or shellfish.
Ronald Goldwater, Dr.
PAREXEL Early Phase Clinical Unit Baltimore, 3001 S. Hanover St., Baltimore, MD 21225, United States