Study in Healthy Subjects to Compare the Concentrations of the Omega-3 Fatty Acids EPA and DHA in Blood When Delivered as Three New Capsules in Relation to the Epanova® Capsule Under Fasting and Fed Conditions

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02359045
• Collaborator: (none)
• Enrollment: 137
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.4
• Patients Per Site Per Month: 25.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Relative Bioavailability; AUC; Cmax; Pharmacokinetics	Drug: D1400147; Drug: D14000136; Drug: D14000137; Drug: Epanova®	Phase 1

Detailed Description

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 conditions.

Study Design

• Study Type: Interventional
• Actual Enrollment: 137 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Randomized, Open-label, Single-center, Cross-over Study in Healthy Subjects to Assess the Relative Bioavailability of EPA and DHA Delivered by Three New Capsule Formulation Prototypes in Relation to the Current Epanova® Capsule Under Fasting (Part 1) and Fed (Part 2) Conditions
• Actual Study Start Date: Feb 12, 2015
• Actual Primary Completion Date: Jul 27, 2015
• Actual Study Completion Date: Jul 27, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1: Treatment A-B-C-D Subjects received a single dose of D1400147 (Treatment A: Omega-3-carboxylic acids 2000 mg uncoated capsules), D14000136 (Treatment B: Omega-3-carboxylic acids 2000 mg coated capsules coat 1), D14000137 (Treatment C: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) and Epanova® (Treatment D: Epanova capsules 1000 mg) under fasted condition.	Drug: D1400147; Treatment A; Drug: D14000136; Treatment B; Drug: D14000137; Treatment C; Drug: Epanova®; Treatment D
Experimental: Part 2: Treatment A-B/C-D Subjects received a single dose of D1400147 (Treatment A: Omega-3-carboxylic acids 2000 mg uncoated capsules), D14000136 (Treatment B: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) or D14000137 (Treatment C: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) and Epanova® (Treatment D: Epanova capsules 1000 mg) under fed condition.	Drug: D1400147; Treatment A; Drug: D14000136; Treatment B; Drug: D14000137; Treatment C; Drug: Epanova®; Treatment D

Outcome Measures

Primary Outcome Measures

1. Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC) Assessed for Eicosapentaenoic Acid (EPA) After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. [Pre-dose: -12, -1 and 0 hours and Post dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours]

   To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC for EPA on baseline subtracted plasma concentrations.

2. AUC Assessed for Docosahexaenoic Acids (DHA) After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. [Pre-dose: -12, -1 and 0 hours and Post dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours]

   To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC for DHA on baseline subtracted plasma concentrations.

3. AUC Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. [Pre-dose: -12, -1 and 0 hours and Post dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours]

   To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.

4. Area Under the Plasma Concentration-time Curve From Time Zero to 72 Hours After Dosing {AUC(0-72)} Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. [Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours]

   To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (0-72) for EPA on baseline subtracted plasma concentrations.

5. AUC (0-72) Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. [Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours]

   To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (0-72) for DHA on baseline subtracted plasma concentrations.

6. AUC (0-72) Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. [Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours]

   To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (0-72) for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.

7. Maximum Observed Plasma Concentration (Cmax) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. [Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours]

   To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of Cmax for EPA on baseline subtracted plasma concentrations.

8. Cmax Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. [Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours]

   To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of Cmax for DHA on baseline subtracted plasma concentrations.

9. Cmax Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. [Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours]

   To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of Cmax for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.

Secondary Outcome Measures

1. Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Analyte Concentration {AUC (Last)} Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. [Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours]

   To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (last) for EPA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentration.

2. AUC (Last) Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. [Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours]

   To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (last) for DHA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentration.

3. AUC (Last) Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. [Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours]

   To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (last) for Total (combined) EPA + DHA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentration.

4. Baseline Concentration (C0) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. [Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours]

   To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of C0 for EPA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentrations.

5. C0 Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. [Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours]

   To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of C0 for DHA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentrations.

6. C0 Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. [Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours]

   To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of C0 for Total (combined) EPA + DHA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentrations.

7. Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. [Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours]

   To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of t½λz for EPA on baseline subtracted plasma concentrations.

8. t½λz Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. [Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours]

   To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of t½λz for DHA on baseline subtracted plasma concentrations.

9. t½λz Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. [Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours]

   To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of t½λz for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.

10. Time to Reach Maximum Observed Concentration (Tmax) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. [Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours]

    To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of tmax for EPA on baseline subtracted plasma concentrations.

11. Tmax Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. [Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours]

    To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of tmax for DHA on baseline subtracted plasma concentrations.

12. Tmax Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. [Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours]

    To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of tmax for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.

13. Terminal Elimination Rate Constant (λz ) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. [Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours]

    To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of λz for EPA on baseline subtracted plasma concentrations.

14. λz Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. [Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours]

    To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of λz for DHA on baseline subtracted plasma concentrations.

15. λz Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. [Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours]

    To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of λz for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.

16. Safety of Omega-3-carboxylic Acids by Assessing Summary of Adverse Events [From screening (within 28 days of first dosing) up to 14 days after last dosing]

    To assess the safety summary of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects

17. Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event [From screening (within 28 days of first dosing) up to 14 days after last dosing.]

    To assess the safety by analyzing the number of subjects with at least one adverse event after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects

18. Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Blood Pressure [From screening (within 28 days of first dosing) up to 14 days after last dosing]

    To evaluate the safety by assessing the number of subjects with clinically significant blood pressure after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects

19. Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Pulse [From screening (within 28 days of first dosing) up to 14 days after last dosing]

    To evaluate the safety by assessing the number of subjects with clinically significant pulse after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects

20. Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant 12-lead Electrocardiograms (ECGs) [From screening (within 28 days of first dosing) up to 14 days after last dosing]

    To evaluate the safety by assessing the number of subjects with clinically significant 12-lead ECGs after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects

21. Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Hematology Parameters [From screening (within 28 days of first dosing) up to 14 days after last dosing]

    To evaluate the safety by assessing the number of subjects with clinically significant hematology parameters after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects

22. Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Clinical Chemistry Laboratory Results [From screening (within 28 days of first dosing) up to 14 days after last dosing]

    To evaluate the safety by assessing the number of subjects with clinically significant clinical chemistry laboratory results after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects

23. Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Urinalysis [From screening (within 28 days of first dosing) up to 14 days after last dosing]

    To evaluate the safety by assessing the number of subjects with clinically significant urinalysis results after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Provision of signed and dated written informed consent prior to any study specific procedures.

• 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.

Exclusion Criteria:

• 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 of drugs.

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Baltimore	Maryland	United States

Sponsors and Collaborators

• AstraZeneca

Investigators

• Principal Investigator: Ronald Goldwater, Dr., PAREXEL Early Phase Clinical Unit Baltimore, 3001 S. Hanover St., Baltimore, MD 21225, United States of America

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT02359045
• Other Study ID Numbers: D5884C00003
• First Posted: Feb 9, 2015
• Last Update Posted: May 1, 2017
• Last Verified: Mar 1, 2017

• Keywords provided by AstraZeneca: Omega-3-carboxylic acids,; Phase I,; Healthy Subjects,; Pharmacokinetics,; Relative bioavailability

Study Results

Participant Flow

Recruitment Details	Participants were recruited at Baltimore, USA. All enrolled participants were included in the study. A total of 137 participants were enrolled (signed ICF) and underwent screening visits, out of which 55 were screen failures and 82 were independently enrolled in the study.
Pre-assignment Detail	All the randomized participants were divided into 2 parts. Part 1- 4 sequence for 4 periods, 4 treatments: (ADBC, BACD, CBDA, DCAB) A- D1400147, B- D14000136, C- D14000137 & D- Epanova. Part 2- 6 sequence for 3 treatments, 3 periods: (ABC, BCA, CAB, ACB, BAC, CBA) A-D1400147, B- D14000136 or D14000137 & C- Epanova.

Arm/Group Title	Part 1	Part 2
Arm/Group Description	Subjects received a single dose of 4 treatments for 4 periods to assess the relative bioavailability and to characterize and compare the PK profiles of the three different prototype capsule formulations (Treatment A, B, C) in relation to Epanova capsules (Treatment D), under fasted conditions. A- D1400147, B- D14000136, C- D14000137 & D- Epanova.	Subjects received a single dose of 3 treatments for 3 periods to assess the relative bioavailability and to characterize and compare the PK profiles of the two different prototype capsule formulations (Treatment A, B) in relation to Epanova capsules (Treatment C), under fed conditions. A-D1400147, B- D14000136 or D14000137 & C- Epanova.
Period Title: Overall Study
STARTED	40	42
COMPLETED	36	39
NOT COMPLETED	4	3

Baseline Characteristics

Arm/Group Title	Part 1	Part 2	Total
Arm/Group Description	Subjects received a single dose of 4 treatments for 4 periods to assess the relative bioavailability and to characterize and compare the PK profiles of the three different prototype capsule formulations (Treatment A, B, C) in relation to Epanova capsules (Treatment D), under fasted conditions. A- D1400147, B- D14000136, C- D14000137 & D- Epanova.	Subjects received a single dose of 3 treatments for 3 periods to assess the relative bioavailability and to characterize and compare the PK profiles of the two different prototype capsule formulations (Treatment A, B) in relation to Epanova capsules (Treatment C), under fed conditions. A-D1400147, B- D14000136 or D14000137 & C- Epanova.	Total of all reporting groups
Overall Participants	40	42	82
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	38.7 (9.97)	37.1 (9.97)	37.9 (9.97)
Sex/Gender, Customized (Number) [Number]
Female	0 0%	5 11.9%	5 6.1%
Male	40 100%	37 88.1%	77 93.9%

Outcome Measures

1. Primary Outcome

Title	Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC) Assessed for Eicosapentaenoic Acid (EPA) After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.
Description	To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC for EPA on baseline subtracted plasma concentrations.
Time Frame	Pre-dose: -12, -1 and 0 hours and Post dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	34	28	24	30	36	38	39
Geometric Mean (Geometric Coefficient of Variation) [µg*h/mL]	2010 (47.9)	1400 (88.6)	744 (81.5)	1720 (54.5)	3460 (34.0)	3010 (34.7)	3450 (33.7)

2. Primary Outcome

Title	AUC Assessed for Docosahexaenoic Acids (DHA) After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.
Description	To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC for DHA on baseline subtracted plasma concentrations.
Time Frame	Pre-dose: -12, -1 and 0 hours and Post dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	6	6	9	6	3	8	2
Geometric Mean (Geometric Coefficient of Variation) [(μg*h/mL)]	783 (72.6)	502 (78.4)	399 (106)	674 (38.4)	791 (40.4)	501 (79.1)	325 (15.8)

3. Primary Outcome

Title	AUC Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.
Description	To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.
Time Frame	Pre-dose: -12, -1 and 0 hours and Post dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	22	15	13	15	19	21	21
Geometric Mean (Geometric Coefficient of Variation) [(nmol*hr/mL)]	10400 (52.3)	6870 (72.7)	4250 (102)	7710 (92.6)	15300 (47.6)	12500 (43.8)	15800 (50.6)

4. Primary Outcome

Title	Area Under the Plasma Concentration-time Curve From Time Zero to 72 Hours After Dosing {AUC(0-72)} Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.
Description	To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (0-72) for EPA on baseline subtracted plasma concentrations.
Time Frame	Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	35	36	35	36	39	40	40
Geometric Mean (Geometric Coefficient of Variation) [(μg*h/mL)]	1680 (37.5)	1080 (74.4)	564 (93.8)	1080 (88.4)	2570 (27.8)	2310 (27.5)	2620 (28.4)

5. Primary Outcome

Title	AUC (0-72) Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.
Description	To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (0-72) for DHA on baseline subtracted plasma concentrations.
Time Frame	Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	35	36	35	35	38	39	40
Geometric Mean (Geometric Coefficient of Variation) [(μg*h/mL)]	577 (65.7)	405 (78.5)	309 (92.0)	339 (135)	610 (57.0)	483 (53.4)	531 (55.6)

6. Primary Outcome

Title	AUC (0-72) Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.
Description	To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (0-72) for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.
Time Frame	Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	35	36	36	36	39	40	40
Geometric Mean (Geometric Coefficient of Variation) [(nmol*hr/mL)]	7200 (44.0)	4560 (80.5)	2710 (92.3)	4470 (96.9)	10200 (31.3)	9030 (28.2)	10100 (32.1)

7. Primary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.
Description	To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of Cmax for EPA on baseline subtracted plasma concentrations.
Time Frame	Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	35	36	36	36	39	40	40
Geometric Mean (Geometric Coefficient of Variation) [(μg/mL)]	93.5 (46.5)	54.5 (94.8)	24.8 (98.1)	50.0 (108)	140 (41.4)	119 (38.2)	156 (40.3)

8. Primary Outcome

Title	Cmax Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.
Description	To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of Cmax for DHA on baseline subtracted plasma concentrations.
Time Frame	Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	35	36	36	36	39	40	40
Geometric Mean (Geometric Coefficient of Variation) [(μg/mL)]	46.7 (44.9)	31.6 (67.7)	19.0 (67.7)	24.0 (83.0)	55.4 (46.3)	45.3 (41.8)	58.0 (50.7)

9. Primary Outcome

Title	Cmax Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.
Description	To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of Cmax for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.
Time Frame	Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	35	36	36	36	39	40	40
Geometric Mean (Geometric Coefficient of Variation) [(nmol/mL)]	447 (46.2)	276 (84.0)	139 (84.4)	241 (91.4)	626 (42.1)	522 (39.9)	690 (42.0)

10. Secondary Outcome

Title	Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Analyte Concentration {AUC (Last)} Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.
Description	To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (last) for EPA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentration.
Time Frame	Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	35	36	36	36	39	40	40
EPA (Baseline Subtracted)	1670 (37.7)	1080 (74.9)	518 (116)	1080 (89.1)	2570 (27.9)	2310 (27.4)	2620 (28.5)
EPA (Baseline Unadjusted)	2800 (31.0)	2190 (41.8)	1620 (42.6)	2150 (44.9)	3730 (27.3)	3500 (24.8)	3850 (25.2)

11. Secondary Outcome

Title	AUC (Last) Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.
Description	To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (last) for DHA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentration.
Time Frame	Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	35	36	36	36	39	40	40
DHA (Baseline Subtracted)	553 (72.3)	391 (83.3)	286 (98.5)	328 (142)	588 (60.2)	484 (57.7)	527 (58.2)
DHA (Baseline Unadjusted)	4770 (22.2)	4700 (24.4)	4510 (19.3)	4520 (20.8)	5340 (28.4)	5290 (26.0)	5360 (27.7)

12. Secondary Outcome

Title	AUC (Last) Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.
Description	To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (last) for Total (combined) EPA + DHA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentration.
Time Frame	Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	35	36	36	36	39	40	40
Total (combined) EPA + DHA(Baseline Subtracted)	7180 (44.5)	4540 (81.4)	2570 (100)	4340 (112)	10200 (31.4)	9040 (28.2)	10200 (32.1)
Total (combined) EPA + DHA(Baseline Unadjusted)	24000 (23.3)	21800 (26.0)	19400 (21.3)	21200 (25.0)	28800 (25.4)	27900 (22.5)	29300 (24.0)

13. Secondary Outcome

Title	Baseline Concentration (C0) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.
Description	To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of C0 for EPA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentrations.
Time Frame	Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	35	36	36	36	39	40	40
EPA (Baseline Subtracted)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
EPA (Baseline Unadjusted)	13.7 (54.2)	13.3 (40.3)	13.2 (42.3)	12.8 (38.8)	14.8 (48.6)	15.6 (38.3)	15.9 (40.6)

14. Secondary Outcome

Title	C0 Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.
Description	To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of C0 for DHA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentrations.
Time Frame	Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	35	36	36	36	39	40	40
DHA (Baseline Subtracted)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
DHA (Baseline Unadjusted)	57.2 (24.8)	59.0 (26.4)	58.0 (20.9)	57.1 (22.7)	65.8 (29.4)	66.6 (26.9)	66.7 (29.1)

15. Secondary Outcome

Title	C0 Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.
Description	To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of C0 for Total (combined) EPA + DHA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentrations.
Time Frame	Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	35	36	36	36	39	40	40
Total (combined) EPA + DHA (Baseline Subtracted)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
Total (combined) EPA + DHA (Baseline Unadjusted)	223 (27.8)	225 (26.6)	223 (21.8)	218 (22.4)	65.8 (29.4)	66.6 (26.9)	66.7 (29.1)

16. Secondary Outcome

Title	Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.
Description	To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of t½λz for EPA on baseline subtracted plasma concentrations.
Time Frame	Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	34	28	24	30	36	38	39
Geometric Mean (Geometric Coefficient of Variation) [(hour)]	25.3 (44.3)	26.0 (49.3)	23.1 (59.7)	29.2 (39.4)	33.8 (42.8)	31.2 (39.2)	33.1 (49.5)

17. Secondary Outcome

Title	t½λz Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.
Description	To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of t½λz for DHA on baseline subtracted plasma concentrations.
Time Frame	Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	6	6	9	6	3	8	2
Geometric Mean (Geometric Coefficient of Variation) [(hour)]	24.1 (88.7)	18.8 (51.7)	13.0 (85.6)	22.5 (77.1)	24.6 (50.3)	18.4 (135)	4.56 (737)

18. Secondary Outcome

Title	t½λz Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.
Description	To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of t½λz for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.
Time Frame	Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	22	15	13	15	19	21	21
Geometric Mean (Geometric Coefficient of Variation) [(hour)]	30.4 (65.5)	23.8 (70.1)	19.1 (76.1)	23.4 (82.1)	33.9 (62.5)	30.3 (67.3)	40.7 (80.7)

19. Secondary Outcome

Title	Time to Reach Maximum Observed Concentration (Tmax) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.
Description	To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of tmax for EPA on baseline subtracted plasma concentrations.
Time Frame	Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	35	36	36	36	39	40	40
Median (Full Range) [(hour)]	6.02	7.50	8.99	7.50	6.00	6.02	6.00

20. Secondary Outcome

Title	Tmax Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.
Description	To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of tmax for DHA on baseline subtracted plasma concentrations.
Time Frame	Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	35	36	36	36	39	40	40
Median (Full Range) [(hour)]	6.00	7.5	7.50	7.49	5.98	6.00	5.49

21. Secondary Outcome

Title	Tmax Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.
Description	To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of tmax for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.
Time Frame	Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	35	36	36	36	39	40	40
Median (Full Range) [(hour)]	6.02	7.50	7.50	7.51	6.00	6.00	6.00

22. Secondary Outcome

Title	Terminal Elimination Rate Constant (λz ) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.
Description	To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of λz for EPA on baseline subtracted plasma concentrations.
Time Frame	Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	34	28	24	30	36	38	39
Geometric Mean (Geometric Coefficient of Variation) [(1/hour)]	0.0274 (44.3)	0.0267 (49.3)	0.0301 (59.7)	0.0237 (39.4)	0.0205 (42.8)	0.0222 (39.2)	0.0209 (49.5)

23. Secondary Outcome

Title	λz Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.
Description	To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of λz for DHA on baseline subtracted plasma concentrations.
Time Frame	Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	6	6	9	6	3	8	2
Geometric Mean (Geometric Coefficient of Variation) [(1/h)]	0.0287 (88.7)	0.0369 (51.7)	0.0531 (85.6)	0.0308 (77.1)	0.0282 (50.3)	0.0377 (135)	0.152 (737)

24. Secondary Outcome

Title	λz Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.
Description	To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of λz for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.
Time Frame	Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	22	15	13	15	19	21	21
Geometric Mean (Geometric Coefficient of Variation) [(1/h)]	0.0228 (65.5)	0.0291 (70.1)	0.0363 (76.1)	0.0297 (82.1)	0.0204 (62.5)	0.0229 (67.3)	0.0170 (80.7)

25. Secondary Outcome

Title	Safety of Omega-3-carboxylic Acids by Assessing Summary of Adverse Events
Description	To assess the safety summary of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects
Time Frame	From screening (within 28 days of first dosing) up to 14 days after last dosing

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	38	39	37	37	39	41	41
Any AE	8 20%	7 16.7%	4 4.9%	5 NaN	3 NaN	3 NaN	3 NaN
Any AE (including events with outcome = death)	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN
Any SAE (including events with outcome = death)	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN
Any AE leading to discontinuationof IP	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	1 NaN

26. Secondary Outcome

Title	Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event
Description	To assess the safety by analyzing the number of subjects with at least one adverse event after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects
Time Frame	From screening (within 28 days of first dosing) up to 14 days after last dosing.

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	38	39	37	37	39	41	41
Eyelid Edema	1	0	0	0	0	0	0
Ocular Hyperemia	1	0	0	0	0	0	0
Vision Blurred	1	0	0	0	0	0	0
Abdominal Distension	0	0	0	1	0	0	0
Abdominal Pain	1	0	0	2	0	0	0
Abdominal Pain Upper	0	0	0	0	0	0	1
Diarrhea	2	2	1	2	0	0	1
Dry Mouth	0	0	0	0	0	0	1
Frequent Bowel Movements	0	0	0	0	1	0	0
Dyspepsia	1	0	0	0	0	0	0
Flatulence	0	1	0	0	0	0	0
Nausea	1	0	0	0	1	0	0
Vomiting	0	0	0	0	0	0	1
Catheter Site Bruise	0	0	1	0	0	0	0
Catheter Site Phlebitis	0	0	0	0	0	1	0
Catheter Site Swelling	0	0	1	0	0	0	0
Vessel Puncture Site Hematoma	0	1	0	0	1	0	0
Hordeolum	0	1	0	0	0	0	1
Dizziness	1	0	0	0	0	0	0
Dysgeusia	0	0	1	0	0	0	0
Headache	2	1	0	1	1	0	0
Presyncope	0	1	0	0	0	0	0
Somnolence	1	0	0	1	0	0	0
Rhinorrhea	1	0	0	0	0	0	0
Sneezing	1	0	0	0	0	0	0
Epistaxis	0	0	0	0	0	1	0
Hepatic Enzyme Increased	0	0	0	0	0	0	1
Neck Pain	0	0	0	0	1	0	0
Acne	0	0	0	0	1	0	0
Hematoma	0	0	0	0	0	1	0

27. Secondary Outcome

Title	Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Blood Pressure
Description	To evaluate the safety by assessing the number of subjects with clinically significant blood pressure after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects
Time Frame	From screening (within 28 days of first dosing) up to 14 days after last dosing

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	38	39	37	37	39	41	41
Number [Participants]	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN

28. Secondary Outcome

Title	Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Pulse
Description	To evaluate the safety by assessing the number of subjects with clinically significant pulse after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects
Time Frame	From screening (within 28 days of first dosing) up to 14 days after last dosing

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	38	39	37	37	39	41	41
Number [Participants]	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN

29. Secondary Outcome

Title	Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant 12-lead Electrocardiograms (ECGs)
Description	To evaluate the safety by assessing the number of subjects with clinically significant 12-lead ECGs after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects
Time Frame	From screening (within 28 days of first dosing) up to 14 days after last dosing

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	39	39	37	37	37	41	41
Number [Participants]	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN

30. Secondary Outcome

Title	Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Hematology Parameters
Description	To evaluate the safety by assessing the number of subjects with clinically significant hematology parameters after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects
Time Frame	From screening (within 28 days of first dosing) up to 14 days after last dosing

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	38	39	37	37	39	41	41
Number [Participants]	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN

31. Secondary Outcome

Title	Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Clinical Chemistry Laboratory Results
Description	To evaluate the safety by assessing the number of subjects with clinically significant clinical chemistry laboratory results after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects
Time Frame	From screening (within 28 days of first dosing) up to 14 days after last dosing

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	38	39	37	37	39	41	41
Number [Participants]	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN

32. Secondary Outcome

Title	Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Urinalysis
Description	To evaluate the safety by assessing the number of subjects with clinically significant urinalysis results after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects
Time Frame	From screening (within 28 days of first dosing) up to 14 days after last dosing

Outcome Measure Data

Analysis Population Description

Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.

Arm/Group Title	Treatment A_Part 1	Treatment B_Part 1	Treatment C_Part 1	Treatment D_Part 1	Treatment A_Part 2	Treatment B_Part 2	Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.	Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Measure Participants	38	39	37	37	39	41	41
Number [Participants]	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN

Adverse Events

Time Frame	Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing).
Adverse Event Reporting Description	The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).
Arm/Group Title	Treatment A_Part 1		Treatment B_Part 1		Treatment C_Part 1		Treatment D_Part 1		Treatment A_Part 2		Treatment B_Part 2		Treatment C_Part 2
Arm/Group Description	Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.		Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.		Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.		Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.		Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.		Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.		Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
All Cause Mortality
	Treatment A_Part 1		Treatment B_Part 1		Treatment C_Part 1		Treatment D_Part 1		Treatment A_Part 2		Treatment B_Part 2		Treatment C_Part 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Treatment A_Part 1		Treatment B_Part 1		Treatment C_Part 1		Treatment D_Part 1		Treatment A_Part 2		Treatment B_Part 2		Treatment C_Part 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/38 (0%)		0/39 (0%)		0/37 (0%)		0/37 (0%)		0/39 (0%)		0/41 (0%)		0/41 (0%)
Other (Not Including Serious) Adverse Events
	Treatment A_Part 1		Treatment B_Part 1		Treatment C_Part 1		Treatment D_Part 1		Treatment A_Part 2		Treatment B_Part 2		Treatment C_Part 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/38 (21.1%)		7/39 (17.9%)		4/37 (10.8%)		5/37 (13.5%)		3/39 (7.7%)		3/41 (7.3%)		3/41 (7.3%)
Eye disorders
Eyelid Edema	1/38 (2.6%)		0/39 (0%)		0/37 (0%)		0/37 (0%)		0/39 (0%)		0/41 (0%)		0/41 (0%)
Ocular Hyperemia	1/38 (2.6%)		0/39 (0%)		0/37 (0%)		0/37 (0%)		0/39 (0%)		0/41 (0%)		0/41 (0%)
Vision Blurred	1/38 (2.6%)		0/39 (0%)		0/37 (0%)		0/37 (0%)		0/39 (0%)		0/41 (0%)		0/41 (0%)
Gastrointestinal disorders
Abdominal Distension	0/38 (0%)		0/39 (0%)		0/37 (0%)		1/37 (2.7%)		0/39 (0%)		0/41 (0%)		0/41 (0%)
Abdominal Pain	1/38 (2.6%)		0/39 (0%)		0/37 (0%)		2/37 (5.4%)		0/39 (0%)		0/41 (0%)		0/41 (0%)
Diarrhea	2/38 (5.3%)		2/39 (5.1%)		1/37 (2.7%)		2/37 (5.4%)		0/39 (0%)		0/41 (0%)		1/41 (2.4%)
Dyspepsia	1/38 (2.6%)		0/39 (0%)		0/37 (0%)		0/37 (0%)		0/39 (0%)		0/41 (0%)		0/41 (0%)
Flatulence	0/38 (0%)		1/39 (2.6%)		0/37 (0%)		0/37 (0%)		0/39 (0%)		0/41 (0%)		0/41 (0%)
Nausea	1/38 (2.6%)		0/39 (0%)		0/37 (0%)		0/37 (0%)		1/39 (2.6%)		0/41 (0%)		0/41 (0%)
Abdominal Pain Upper	0/38 (0%)		0/39 (0%)		0/37 (0%)		0/37 (0%)		0/39 (0%)		0/41 (0%)		1/41 (2.4%)
Dry Mouth	0/38 (0%)		0/39 (0%)		0/37 (0%)		0/37 (0%)		0/39 (0%)		0/41 (0%)		1/41 (2.4%)
Frequent Bowel Movements	0/38 (0%)		0/39 (0%)		0/37 (0%)		0/37 (0%)		1/39 (2.6%)		0/41 (0%)		0/41 (0%)
Vomiting	0/38 (0%)		0/39 (0%)		0/37 (0%)		0/37 (0%)		0/39 (0%)		0/41 (0%)		1/41 (2.4%)
General disorders
Catheter Site Bruise	0/38 (0%)		0/39 (0%)		1/37 (2.7%)		0/37 (0%)		0/39 (0%)		0/41 (0%)		0/41 (0%)
Catheter Site Swelling	0/38 (0%)		0/39 (0%)		1/37 (2.7%)		0/37 (0%)		0/39 (0%)		0/41 (0%)		0/41 (0%)
Vessel Puncture Site Hematoma	0/38 (0%)		1/39 (2.6%)		0/37 (0%)		0/37 (0%)		1/39 (2.6%)		0/41 (0%)		0/41 (0%)
Catheter Site Phlebitis	0/38 (0%)		0/39 (0%)		0/37 (0%)		0/37 (0%)		0/39 (0%)		1/41 (2.4%)		0/41 (0%)
Infections and infestations
Hordeolum	0/38 (0%)		1/39 (2.6%)		0/37 (0%)		0/37 (0%)		0/39 (0%)		0/41 (0%)		1/41 (2.4%)
Musculoskeletal and connective tissue disorders
Neck Pain	0/38 (0%)		0/39 (0%)		0/37 (0%)		0/37 (0%)		1/39 (2.6%)		0/41 (0%)		0/41 (0%)
Nervous system disorders
Dizziness	1/38 (2.6%)		0/39 (0%)		0/37 (0%)		0/37 (0%)		0/39 (0%)		0/41 (0%)		0/41 (0%)
Dysgeusia	0/38 (0%)		0/39 (0%)		1/37 (2.7%)		0/37 (0%)		0/39 (0%)		0/41 (0%)		0/41 (0%)
Headache	2/38 (5.3%)		1/39 (2.6%)		0/37 (0%)		1/37 (2.7%)		1/39 (2.6%)		0/41 (0%)		0/41 (0%)
Presyncope	0/38 (0%)		1/39 (2.6%)		0/37 (0%)		0/37 (0%)		0/39 (0%)		0/41 (0%)		0/41 (0%)
Somnolence	1/38 (2.6%)		0/39 (0%)		0/37 (0%)		1/37 (2.7%)		0/39 (0%)		0/41 (0%)		0/41 (0%)
Respiratory, thoracic and mediastinal disorders
Rhinorrhea	1/38 (2.6%)		0/39 (0%)		0/37 (0%)		0/37 (0%)		0/39 (0%)		0/41 (0%)		0/41 (0%)
Sneezing	1/38 (2.6%)		0/39 (0%)		0/37 (0%)		0/37 (0%)		0/39 (0%)		0/41 (0%)		0/41 (0%)
Epistaxis	0/38 (0%)		0/39 (0%)		0/37 (0%)		0/37 (0%)		0/39 (0%)		1/41 (2.4%)		0/41 (0%)
Skin and subcutaneous tissue disorders
Acne	0/38 (0%)		0/39 (0%)		0/37 (0%)		0/37 (0%)		1/39 (2.6%)		0/41 (0%)		0/41 (0%)
Vascular disorders
Hematoma	0/38 (0%)		0/39 (0%)		0/37 (0%)		0/37 (0%)		0/39 (0%)		1/41 (2.4%)		0/41 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

If a publication (e.g., in a scientific journal) based on the results of this study is envisaged, approval from AstraZeneca will be obtained and a draft manuscript will be submitted to AstraZeneca for scrutiny and comment. The choice of conduit will be mutually agreed on by the Principal Investigator and AstraZeneca.