Trial Outcomes & Findings for 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 (NCT NCT02359045)

NCT ID: NCT02359045

Last Updated: 2017-05-01

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 137 participants
• Primary outcome timeframe: 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
• Results posted on: 2017-05-01

Participant Flow

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.

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.

Participant milestones

Measure	Part 1 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.	Part 2 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.
Overall Study STARTED	40	42
Overall Study COMPLETED	36	39
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Measure	Part 1 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.	Part 2 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.
Overall Study Eligibility criteria not fulfilled	3	1
Overall Study Lost to Follow-up	1	1
Overall Study Adverse Event	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Part 1 n=40 Participants 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.	Part 2 n=42 Participants 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 n=82 Participants Total of all reporting groups
Age, Continuous	38.7 Years STANDARD_DEVIATION 9.97 • n=5 Participants	37.1 Years STANDARD_DEVIATION 9.97 • n=7 Participants	37.9 Years STANDARD_DEVIATION 9.97 • n=5 Participants
Sex/Gender, Customized Female	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Sex/Gender, Customized Male	40 Participants n=5 Participants	37 Participants n=7 Participants	77 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

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

PRIMARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Treatment A_Part 1 n=6 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Treatment B_Part 1 n=6 Participants Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Treatment C_Part 1 n=9 Participants Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Treatment D_Part 1 n=6 Participants Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Treatment A_Part 2 n=3 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Treatment B_Part 2 n=8 Participants 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.	Treatment C_Part 2 n=2 Participants Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
AUC Assessed for Docosahexaenoic Acids (DHA) After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.	783 (μg*h/mL) Geometric Coefficient of Variation 72.6	502 (μg*h/mL) Geometric Coefficient of Variation 78.4	399 (μg*h/mL) Geometric Coefficient of Variation 106	674 (μg*h/mL) Geometric Coefficient of Variation 38.4	791 (μg*h/mL) Geometric Coefficient of Variation 40.4	501 (μg*h/mL) Geometric Coefficient of Variation 79.1	325 (μg*h/mL) Geometric Coefficient of Variation 15.8

PRIMARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Treatment A_Part 1 n=22 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Treatment B_Part 1 n=15 Participants Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Treatment C_Part 1 n=13 Participants Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Treatment D_Part 1 n=15 Participants Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Treatment A_Part 2 n=19 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Treatment B_Part 2 n=21 Participants 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.	Treatment C_Part 2 n=21 Participants Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
AUC Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.	10400 (nmol*hr/mL) Geometric Coefficient of Variation 52.3	6870 (nmol*hr/mL) Geometric Coefficient of Variation 72.7	4250 (nmol*hr/mL) Geometric Coefficient of Variation 102	7710 (nmol*hr/mL) Geometric Coefficient of Variation 92.6	15300 (nmol*hr/mL) Geometric Coefficient of Variation 47.6	12500 (nmol*hr/mL) Geometric Coefficient of Variation 43.8	15800 (nmol*hr/mL) Geometric Coefficient of Variation 50.6

PRIMARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

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

PRIMARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Treatment A_Part 1 n=35 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Treatment B_Part 1 n=36 Participants Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Treatment C_Part 1 n=35 Participants Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Treatment D_Part 1 n=35 Participants Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Treatment A_Part 2 n=38 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Treatment B_Part 2 n=39 Participants 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.	Treatment C_Part 2 n=40 Participants Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
AUC (0-72) Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.	577 (μg*h/mL) Geometric Coefficient of Variation 65.7	405 (μg*h/mL) Geometric Coefficient of Variation 78.5	309 (μg*h/mL) Geometric Coefficient of Variation 92.0	339 (μg*h/mL) Geometric Coefficient of Variation 135	610 (μg*h/mL) Geometric Coefficient of Variation 57.0	483 (μg*h/mL) Geometric Coefficient of Variation 53.4	531 (μg*h/mL) Geometric Coefficient of Variation 55.6

PRIMARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Treatment A_Part 1 n=35 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Treatment B_Part 1 n=36 Participants Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Treatment C_Part 1 n=36 Participants Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Treatment D_Part 1 n=36 Participants Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Treatment A_Part 2 n=39 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Treatment B_Part 2 n=40 Participants 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.	Treatment C_Part 2 n=40 Participants Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
AUC (0-72) Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.	7200 (nmol*hr/mL) Geometric Coefficient of Variation 44.0	4560 (nmol*hr/mL) Geometric Coefficient of Variation 80.5	2710 (nmol*hr/mL) Geometric Coefficient of Variation 92.3	4470 (nmol*hr/mL) Geometric Coefficient of Variation 96.9	10200 (nmol*hr/mL) Geometric Coefficient of Variation 31.3	9030 (nmol*hr/mL) Geometric Coefficient of Variation 28.2	10100 (nmol*hr/mL) Geometric Coefficient of Variation 32.1

PRIMARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Treatment A_Part 1 n=35 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Treatment B_Part 1 n=36 Participants Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Treatment C_Part 1 n=36 Participants Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Treatment D_Part 1 n=36 Participants Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Treatment A_Part 2 n=39 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Treatment B_Part 2 n=40 Participants 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.	Treatment C_Part 2 n=40 Participants Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Maximum Observed Plasma Concentration (Cmax) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.	93.5 (μg/mL) Geometric Coefficient of Variation 46.5	54.5 (μg/mL) Geometric Coefficient of Variation 94.8	24.8 (μg/mL) Geometric Coefficient of Variation 98.1	50.0 (μg/mL) Geometric Coefficient of Variation 108	140 (μg/mL) Geometric Coefficient of Variation 41.4	119 (μg/mL) Geometric Coefficient of Variation 38.2	156 (μg/mL) Geometric Coefficient of Variation 40.3

PRIMARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Treatment A_Part 1 n=35 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Treatment B_Part 1 n=36 Participants Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Treatment C_Part 1 n=36 Participants Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Treatment D_Part 1 n=36 Participants Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Treatment A_Part 2 n=39 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Treatment B_Part 2 n=40 Participants 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.	Treatment C_Part 2 n=40 Participants Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Cmax Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.	46.7 (μg/mL) Geometric Coefficient of Variation 44.9	31.6 (μg/mL) Geometric Coefficient of Variation 67.7	19.0 (μg/mL) Geometric Coefficient of Variation 67.7	24.0 (μg/mL) Geometric Coefficient of Variation 83.0	55.4 (μg/mL) Geometric Coefficient of Variation 46.3	45.3 (μg/mL) Geometric Coefficient of Variation 41.8	58.0 (μg/mL) Geometric Coefficient of Variation 50.7

PRIMARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Treatment A_Part 1 n=35 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Treatment B_Part 1 n=36 Participants Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Treatment C_Part 1 n=36 Participants Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Treatment D_Part 1 n=36 Participants Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Treatment A_Part 2 n=39 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Treatment B_Part 2 n=40 Participants 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.	Treatment C_Part 2 n=40 Participants Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Cmax Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.	447 (nmol/mL) Geometric Coefficient of Variation 46.2	276 (nmol/mL) Geometric Coefficient of Variation 84.0	139 (nmol/mL) Geometric Coefficient of Variation 84.4	241 (nmol/mL) Geometric Coefficient of Variation 91.4	626 (nmol/mL) Geometric Coefficient of Variation 42.1	522 (nmol/mL) Geometric Coefficient of Variation 39.9	690 (nmol/mL) Geometric Coefficient of Variation 42.0

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

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

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Treatment A_Part 1 n=35 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Treatment B_Part 1 n=36 Participants Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Treatment C_Part 1 n=36 Participants Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Treatment D_Part 1 n=36 Participants Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Treatment A_Part 2 n=39 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Treatment B_Part 2 n=40 Participants 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.	Treatment C_Part 2 n=40 Participants Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
AUC (Last) Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. DHA (Baseline Subtracted)	553 (μg*h/mL) Geometric Coefficient of Variation 72.3	391 (μg*h/mL) Geometric Coefficient of Variation 83.3	286 (μg*h/mL) Geometric Coefficient of Variation 98.5	328 (μg*h/mL) Geometric Coefficient of Variation 142	588 (μg*h/mL) Geometric Coefficient of Variation 60.2	484 (μg*h/mL) Geometric Coefficient of Variation 57.7	527 (μg*h/mL) Geometric Coefficient of Variation 58.2
AUC (Last) Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. DHA (Baseline Unadjusted)	4770 (μg*h/mL) Geometric Coefficient of Variation 22.2	4700 (μg*h/mL) Geometric Coefficient of Variation 24.4	4510 (μg*h/mL) Geometric Coefficient of Variation 19.3	4520 (μg*h/mL) Geometric Coefficient of Variation 20.8	5340 (μg*h/mL) Geometric Coefficient of Variation 28.4	5290 (μg*h/mL) Geometric Coefficient of Variation 26.0	5360 (μg*h/mL) Geometric Coefficient of Variation 27.7

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Treatment A_Part 1 n=35 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Treatment B_Part 1 n=36 Participants Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Treatment C_Part 1 n=36 Participants Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Treatment D_Part 1 n=36 Participants Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Treatment A_Part 2 n=39 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Treatment B_Part 2 n=40 Participants 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.	Treatment C_Part 2 n=40 Participants Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
AUC (Last) Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. Total (combined) EPA + DHA(Baseline Subtracted)	7180 (nmol*hr/mL) Geometric Coefficient of Variation 44.5	4540 (nmol*hr/mL) Geometric Coefficient of Variation 81.4	2570 (nmol*hr/mL) Geometric Coefficient of Variation 100	4340 (nmol*hr/mL) Geometric Coefficient of Variation 112	10200 (nmol*hr/mL) Geometric Coefficient of Variation 31.4	9040 (nmol*hr/mL) Geometric Coefficient of Variation 28.2	10200 (nmol*hr/mL) Geometric Coefficient of Variation 32.1
AUC (Last) Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. Total (combined) EPA + DHA(Baseline Unadjusted)	24000 (nmol*hr/mL) Geometric Coefficient of Variation 23.3	21800 (nmol*hr/mL) Geometric Coefficient of Variation 26.0	19400 (nmol*hr/mL) Geometric Coefficient of Variation 21.3	21200 (nmol*hr/mL) Geometric Coefficient of Variation 25.0	28800 (nmol*hr/mL) Geometric Coefficient of Variation 25.4	27900 (nmol*hr/mL) Geometric Coefficient of Variation 22.5	29300 (nmol*hr/mL) Geometric Coefficient of Variation 24.0

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Treatment A_Part 1 n=35 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Treatment B_Part 1 n=36 Participants Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Treatment C_Part 1 n=36 Participants Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Treatment D_Part 1 n=36 Participants Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Treatment A_Part 2 n=39 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Treatment B_Part 2 n=40 Participants 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.	Treatment C_Part 2 n=40 Participants Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Baseline Concentration (C0) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. EPA (Baseline Subtracted)	0 (μg/mL) Geometric Coefficient of Variation 0	0 (μg/mL) Geometric Coefficient of Variation 0	0 (μg/mL) Geometric Coefficient of Variation 0	0 (μg/mL) Geometric Coefficient of Variation 0	0 (μg/mL) Geometric Coefficient of Variation 0	0 (μg/mL) Geometric Coefficient of Variation 0	0 (μg/mL) Geometric Coefficient of Variation 0
Baseline Concentration (C0) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. EPA (Baseline Unadjusted)	13.7 (μg/mL) Geometric Coefficient of Variation 54.2	13.3 (μg/mL) Geometric Coefficient of Variation 40.3	13.2 (μg/mL) Geometric Coefficient of Variation 42.3	12.8 (μg/mL) Geometric Coefficient of Variation 38.8	14.8 (μg/mL) Geometric Coefficient of Variation 48.6	15.6 (μg/mL) Geometric Coefficient of Variation 38.3	15.9 (μg/mL) Geometric Coefficient of Variation 40.6

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Treatment A_Part 1 n=35 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Treatment B_Part 1 n=36 Participants Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Treatment C_Part 1 n=36 Participants Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Treatment D_Part 1 n=36 Participants Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Treatment A_Part 2 n=39 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Treatment B_Part 2 n=40 Participants 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.	Treatment C_Part 2 n=40 Participants Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
C0 Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. DHA (Baseline Subtracted)	0 (μg/mL) Geometric Coefficient of Variation 0	0 (μg/mL) Geometric Coefficient of Variation 0	0 (μg/mL) Geometric Coefficient of Variation 0	0 (μg/mL) Geometric Coefficient of Variation 0	0 (μg/mL) Geometric Coefficient of Variation 0	0 (μg/mL) Geometric Coefficient of Variation 0	0 (μg/mL) Geometric Coefficient of Variation 0
C0 Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. DHA (Baseline Unadjusted)	57.2 (μg/mL) Geometric Coefficient of Variation 24.8	59.0 (μg/mL) Geometric Coefficient of Variation 26.4	58.0 (μg/mL) Geometric Coefficient of Variation 20.9	57.1 (μg/mL) Geometric Coefficient of Variation 22.7	65.8 (μg/mL) Geometric Coefficient of Variation 29.4	66.6 (μg/mL) Geometric Coefficient of Variation 26.9	66.7 (μg/mL) Geometric Coefficient of Variation 29.1

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Treatment A_Part 1 n=35 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Treatment B_Part 1 n=36 Participants Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Treatment C_Part 1 n=36 Participants Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Treatment D_Part 1 n=36 Participants Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Treatment A_Part 2 n=39 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Treatment B_Part 2 n=40 Participants 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.	Treatment C_Part 2 n=40 Participants Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
C0 Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. Total (combined) EPA + DHA (Baseline Subtracted)	0 (nmol/mL) Geometric Coefficient of Variation 0	0 (nmol/mL) Geometric Coefficient of Variation 0	0 (nmol/mL) Geometric Coefficient of Variation 0	0 (nmol/mL) Geometric Coefficient of Variation 0	0 (nmol/mL) Geometric Coefficient of Variation 0	0 (nmol/mL) Geometric Coefficient of Variation 0	0 (nmol/mL) Geometric Coefficient of Variation 0
C0 Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. Total (combined) EPA + DHA (Baseline Unadjusted)	223 (nmol/mL) Geometric Coefficient of Variation 27.8	225 (nmol/mL) Geometric Coefficient of Variation 26.6	223 (nmol/mL) Geometric Coefficient of Variation 21.8	218 (nmol/mL) Geometric Coefficient of Variation 22.4	65.8 (nmol/mL) Geometric Coefficient of Variation 29.4	66.6 (nmol/mL) Geometric Coefficient of Variation 26.9	66.7 (nmol/mL) Geometric Coefficient of Variation 29.1

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

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

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Treatment A_Part 1 n=6 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Treatment B_Part 1 n=6 Participants Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Treatment C_Part 1 n=9 Participants Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Treatment D_Part 1 n=6 Participants Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Treatment A_Part 2 n=3 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Treatment B_Part 2 n=8 Participants 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.	Treatment C_Part 2 n=2 Participants Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
t½λz Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.	24.1 (hour) Geometric Coefficient of Variation 88.7	18.8 (hour) Geometric Coefficient of Variation 51.7	13.0 (hour) Geometric Coefficient of Variation 85.6	22.5 (hour) Geometric Coefficient of Variation 77.1	24.6 (hour) Geometric Coefficient of Variation 50.3	18.4 (hour) Geometric Coefficient of Variation 135	4.56 (hour) Geometric Coefficient of Variation 737

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Treatment A_Part 1 n=22 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Treatment B_Part 1 n=15 Participants Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Treatment C_Part 1 n=13 Participants Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Treatment D_Part 1 n=15 Participants Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Treatment A_Part 2 n=19 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Treatment B_Part 2 n=21 Participants 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.	Treatment C_Part 2 n=21 Participants Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
t½λz Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.	30.4 (hour) Geometric Coefficient of Variation 65.5	23.8 (hour) Geometric Coefficient of Variation 70.1	19.1 (hour) Geometric Coefficient of Variation 76.1	23.4 (hour) Geometric Coefficient of Variation 82.1	33.9 (hour) Geometric Coefficient of Variation 62.5	30.3 (hour) Geometric Coefficient of Variation 67.3	40.7 (hour) Geometric Coefficient of Variation 80.7

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Treatment A_Part 1 n=35 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Treatment B_Part 1 n=36 Participants Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Treatment C_Part 1 n=36 Participants Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Treatment D_Part 1 n=36 Participants Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Treatment A_Part 2 n=39 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Treatment B_Part 2 n=40 Participants 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.	Treatment C_Part 2 n=40 Participants Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Time to Reach Maximum Observed Concentration (Tmax) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.	6.02 (hour) Interval 5.0 to 9.0	7.50 (hour) Interval 5.0 to 12.0	8.99 (hour) Interval 5.98 to 36.0	7.50 (hour) Interval 5.98 to 24.0	6.00 (hour) Interval 2.0 to 12.0	6.02 (hour) Interval 3.0 to 24.0	6.00 (hour) Interval 4.0 to 12.0

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Treatment A_Part 1 n=35 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Treatment B_Part 1 n=36 Participants Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Treatment C_Part 1 n=36 Participants Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Treatment D_Part 1 n=36 Participants Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Treatment A_Part 2 n=39 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Treatment B_Part 2 n=40 Participants 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.	Treatment C_Part 2 n=40 Participants Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Tmax Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.	6.00 (hour) Interval 5.0 to 9.03	7.5 (hour) Interval 2.0 to 12.0	7.50 (hour) Interval 2.02 to 72.0	7.49 (hour) Interval 3.95 to 24.0	5.98 (hour) Interval 2.0 to 9.02	6.00 (hour) Interval 3.0 to 72.1	5.49 (hour) Interval 3.0 to 8.97

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Treatment A_Part 1 n=35 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Treatment B_Part 1 n=36 Participants Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Treatment C_Part 1 n=36 Participants Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Treatment D_Part 1 n=36 Participants Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Treatment A_Part 2 n=39 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Treatment B_Part 2 n=40 Participants 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.	Treatment C_Part 2 n=40 Participants Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Tmax Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.	6.02 (hour) Interval 5.0 to 9.03	7.50 (hour) Interval 2.0 to 12.0	7.50 (hour) Interval 4.98 to 72.0	7.51 (hour) Interval 5.0 to 24.0	6.00 (hour) Interval 2.0 to 9.02	6.00 (hour) Interval 3.0 to 8.98	6.00 (hour) Interval 3.0 to 8.97

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Treatment A_Part 1 n=34 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Treatment B_Part 1 n=28 Participants Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Treatment C_Part 1 n=24 Participants Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Treatment D_Part 1 n=30 Participants Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Treatment A_Part 2 n=36 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Treatment B_Part 2 n=38 Participants 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.	Treatment C_Part 2 n=39 Participants Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Terminal Elimination Rate Constant (λz ) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.	0.0274 (1/hour) Geometric Coefficient of Variation 44.3	0.0267 (1/hour) Geometric Coefficient of Variation 49.3	0.0301 (1/hour) Geometric Coefficient of Variation 59.7	0.0237 (1/hour) Geometric Coefficient of Variation 39.4	0.0205 (1/hour) Geometric Coefficient of Variation 42.8	0.0222 (1/hour) Geometric Coefficient of Variation 39.2	0.0209 (1/hour) Geometric Coefficient of Variation 49.5

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Treatment A_Part 1 n=6 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Treatment B_Part 1 n=6 Participants Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Treatment C_Part 1 n=9 Participants Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Treatment D_Part 1 n=6 Participants Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Treatment A_Part 2 n=3 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Treatment B_Part 2 n=8 Participants 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.	Treatment C_Part 2 n=2 Participants Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
λz Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.	0.0287 (1/h) Geometric Coefficient of Variation 88.7	0.0369 (1/h) Geometric Coefficient of Variation 51.7	0.0531 (1/h) Geometric Coefficient of Variation 85.6	0.0308 (1/h) Geometric Coefficient of Variation 77.1	0.0282 (1/h) Geometric Coefficient of Variation 50.3	0.0377 (1/h) Geometric Coefficient of Variation 135	0.152 (1/h) Geometric Coefficient of Variation 737

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Treatment A_Part 1 n=22 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Treatment B_Part 1 n=15 Participants Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Treatment C_Part 1 n=13 Participants Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Treatment D_Part 1 n=15 Participants Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Treatment A_Part 2 n=19 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Treatment B_Part 2 n=21 Participants 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.	Treatment C_Part 2 n=21 Participants Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
λz Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.	0.0228 (1/h) Geometric Coefficient of Variation 65.5	0.0291 (1/h) Geometric Coefficient of Variation 70.1	0.0363 (1/h) Geometric Coefficient of Variation 76.1	0.0297 (1/h) Geometric Coefficient of Variation 82.1	0.0204 (1/h) Geometric Coefficient of Variation 62.5	0.0229 (1/h) Geometric Coefficient of Variation 67.3	0.0170 (1/h) Geometric Coefficient of Variation 80.7

SECONDARY outcome

Timeframe: From screening (within 28 days of first dosing) up to 14 days after last dosing

Population: 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.

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

Outcome measures

Measure	Treatment A_Part 1 n=38 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Treatment B_Part 1 n=39 Participants Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Treatment C_Part 1 n=37 Participants Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Treatment D_Part 1 n=37 Participants Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Treatment A_Part 2 n=39 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Treatment B_Part 2 n=41 Participants 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.	Treatment C_Part 2 n=41 Participants Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Safety of Omega-3-carboxylic Acids by Assessing Summary of Adverse Events Any AE	8 Participants	7 Participants	4 Participants	5 Participants	3 Participants	3 Participants	3 Participants
Safety of Omega-3-carboxylic Acids by Assessing Summary of Adverse Events Any AE (including events with outcome = death)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety of Omega-3-carboxylic Acids by Assessing Summary of Adverse Events Any SAE (including events with outcome = death)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety of Omega-3-carboxylic Acids by Assessing Summary of Adverse Events Any AE leading to discontinuationof IP	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From screening (within 28 days of first dosing) up to 14 days after last dosing.

Population: 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.

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

Outcome measures

Measure	Treatment A_Part 1 n=38 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Treatment B_Part 1 n=39 Participants Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Treatment C_Part 1 n=37 Participants Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Treatment D_Part 1 n=37 Participants Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Treatment A_Part 2 n=39 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Treatment B_Part 2 n=41 Participants 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.	Treatment C_Part 2 n=41 Participants Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Abdominal Pain Upper	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	1 Partcipants
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Dry Mouth	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	1 Partcipants
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Nausea	1 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	1 Partcipants	0 Partcipants	0 Partcipants
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Catheter Site Swelling	0 Partcipants	0 Partcipants	1 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Vessel Puncture Site Hematoma	0 Partcipants	1 Partcipants	0 Partcipants	0 Partcipants	1 Partcipants	0 Partcipants	0 Partcipants
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Dizziness	1 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Dysgeusia	0 Partcipants	0 Partcipants	1 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Presyncope	0 Partcipants	1 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Somnolence	1 Partcipants	0 Partcipants	0 Partcipants	1 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Rhinorrhea	1 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Hepatic Enzyme Increased	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	1 Partcipants
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Hematoma	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	1 Partcipants	0 Partcipants
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Sneezing	1 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Eyelid Edema	1 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Ocular Hyperemia	1 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Vision Blurred	1 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Abdominal Distension	0 Partcipants	0 Partcipants	0 Partcipants	1 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Abdominal Pain	1 Partcipants	0 Partcipants	0 Partcipants	2 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Diarrhea	2 Partcipants	2 Partcipants	1 Partcipants	2 Partcipants	0 Partcipants	0 Partcipants	1 Partcipants
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Frequent Bowel Movements	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	1 Partcipants	0 Partcipants	0 Partcipants
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Dyspepsia	1 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Flatulence	0 Partcipants	1 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Vomiting	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	1 Partcipants
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Catheter Site Bruise	0 Partcipants	0 Partcipants	1 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Catheter Site Phlebitis	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	1 Partcipants	0 Partcipants
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Hordeolum	0 Partcipants	1 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	1 Partcipants
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Headache	2 Partcipants	1 Partcipants	0 Partcipants	1 Partcipants	1 Partcipants	0 Partcipants	0 Partcipants
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Epistaxis	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	1 Partcipants	0 Partcipants
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Neck Pain	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	1 Partcipants	0 Partcipants	0 Partcipants
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event Acne	0 Partcipants	0 Partcipants	0 Partcipants	0 Partcipants	1 Partcipants	0 Partcipants	0 Partcipants

SECONDARY outcome

Timeframe: From screening (within 28 days of first dosing) up to 14 days after last dosing

Population: 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.

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

Outcome measures

Measure	Treatment A_Part 1 n=38 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Treatment B_Part 1 n=39 Participants Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Treatment C_Part 1 n=37 Participants Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Treatment D_Part 1 n=37 Participants Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Treatment A_Part 2 n=39 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Treatment B_Part 2 n=41 Participants 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.	Treatment C_Part 2 n=41 Participants Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Blood Pressure	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From screening (within 28 days of first dosing) up to 14 days after last dosing

Population: 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.

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

Outcome measures

Measure	Treatment A_Part 1 n=38 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Treatment B_Part 1 n=39 Participants Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Treatment C_Part 1 n=37 Participants Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Treatment D_Part 1 n=37 Participants Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Treatment A_Part 2 n=39 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Treatment B_Part 2 n=41 Participants 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.	Treatment C_Part 2 n=41 Participants Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Pulse	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From screening (within 28 days of first dosing) up to 14 days after last dosing

Population: 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.

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

Outcome measures

Measure	Treatment A_Part 1 n=39 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Treatment B_Part 1 n=39 Participants Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Treatment C_Part 1 n=37 Participants Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Treatment D_Part 1 n=37 Participants Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Treatment A_Part 2 n=37 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Treatment B_Part 2 n=41 Participants 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.	Treatment C_Part 2 n=41 Participants Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant 12-lead Electrocardiograms (ECGs)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From screening (within 28 days of first dosing) up to 14 days after last dosing

Population: 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.

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

Outcome measures

Measure	Treatment A_Part 1 n=38 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Treatment B_Part 1 n=39 Participants Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Treatment C_Part 1 n=37 Participants Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Treatment D_Part 1 n=37 Participants Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Treatment A_Part 2 n=39 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Treatment B_Part 2 n=41 Participants 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.	Treatment C_Part 2 n=41 Participants Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Hematology Parameters	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From screening (within 28 days of first dosing) up to 14 days after last dosing

Population: 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.

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

Outcome measures

Measure	Treatment A_Part 1 n=38 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Treatment B_Part 1 n=39 Participants Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Treatment C_Part 1 n=37 Participants Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Treatment D_Part 1 n=37 Participants Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Treatment A_Part 2 n=39 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Treatment B_Part 2 n=41 Participants 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.	Treatment C_Part 2 n=41 Participants Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Clinical Chemistry Laboratory Results	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From screening (within 28 days of first dosing) up to 14 days after last dosing

Population: 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.

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

Outcome measures

Measure	Treatment A_Part 1 n=38 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Treatment B_Part 1 n=39 Participants Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Treatment C_Part 1 n=37 Participants Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Treatment D_Part 1 n=37 Participants Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Treatment A_Part 2 n=39 Participants Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Treatment B_Part 2 n=41 Participants 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.	Treatment C_Part 2 n=41 Participants Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Urinalysis	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Treatment A_Part 1

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Treatment B_Part 1

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Treatment C_Part 1

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Treatment D_Part 1

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Treatment A_Part 2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Treatment B_Part 2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Treatment C_Part 2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment A_Part 1 n=38 participants at risk Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.	Treatment B_Part 1 n=39 participants at risk Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.	Treatment C_Part 1 n=37 participants at risk Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.	Treatment D_Part 1 n=37 participants at risk Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.	Treatment A_Part 2 n=39 participants at risk Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.	Treatment B_Part 2 n=41 participants at risk 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.	Treatment C_Part 2 n=41 participants at risk Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
Eye disorders Eyelid Edema	2.6% 1/38 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).
Eye disorders Ocular Hyperemia	2.6% 1/38 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).
Eye disorders Vision Blurred	2.6% 1/38 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).
Gastrointestinal disorders Abdominal Distension	0.00% 0/38 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	2.7% 1/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).
Gastrointestinal disorders Abdominal Pain	2.6% 1/38 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	5.4% 2/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).
Gastrointestinal disorders Diarrhea	5.3% 2/38 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	5.1% 2/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	2.7% 1/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	5.4% 2/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	2.4% 1/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).
Gastrointestinal disorders Dyspepsia	2.6% 1/38 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).
Gastrointestinal disorders Flatulence	0.00% 0/38 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	2.6% 1/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).
Gastrointestinal disorders Nausea	2.6% 1/38 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	2.6% 1/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/38 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	2.4% 1/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).
Gastrointestinal disorders Dry Mouth	0.00% 0/38 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	2.4% 1/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).
Gastrointestinal disorders Frequent Bowel Movements	0.00% 0/38 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	2.6% 1/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).
Gastrointestinal disorders Vomiting	0.00% 0/38 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	2.4% 1/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).
General disorders Catheter Site Bruise	0.00% 0/38 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	2.7% 1/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).
General disorders Catheter Site Swelling	0.00% 0/38 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	2.7% 1/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).
General disorders Vessel Puncture Site Hematoma	0.00% 0/38 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	2.6% 1/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	2.6% 1/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).
General disorders Catheter Site Phlebitis	0.00% 0/38 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	2.4% 1/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).
Infections and infestations Hordeolum	0.00% 0/38 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	2.6% 1/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	2.4% 1/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).
Nervous system disorders Dizziness	2.6% 1/38 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).
Nervous system disorders Dysgeusia	0.00% 0/38 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	2.7% 1/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).
Nervous system disorders Headache	5.3% 2/38 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	2.6% 1/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	2.7% 1/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	2.6% 1/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).
Nervous system disorders Presyncope	0.00% 0/38 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	2.6% 1/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).
Nervous system disorders Somnolence	2.6% 1/38 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	2.7% 1/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/38 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	2.6% 1/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).
Respiratory, thoracic and mediastinal disorders Rhinorrhea	2.6% 1/38 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).
Respiratory, thoracic and mediastinal disorders Sneezing	2.6% 1/38 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/38 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	2.4% 1/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).
Skin and subcutaneous tissue disorders Acne	0.00% 0/38 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	2.6% 1/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).
Vascular disorders Hematoma	0.00% 0/38 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/37 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/39 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	2.4% 1/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).	0.00% 0/41 • Part 1: approximately 12 weeks and Part 2: approximately 10 weeks (i.e. from screening ≤28days until 10-14 days after last dosing). The safety of subjects were ensured from the pre-defined time points for screening until follow-up (10 to 14 days after last dosing).

Additional Information

Global Clinical Leader

AstraZeneca AB

Phone: +46317761000

Email: ClinicalTrialTransparency@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER