| Primary | 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. | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | µg*h/mL | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. | | OG002 | Treatment C_Part 1 | Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions. | | OG003 | Treatment D_Part 1 | Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions. | | OG004 | Treatment A_Part 2 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions. | | OG005 | Treatment B_Part 2 | 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. | | OG006 | Treatment C_Part 2 | Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions. |
| | Units | Counts |
|---|
| Participants | - OG00034
- OG00128
- OG00224
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0002010± 47.9
- OG0011400± 88.6
- OG002744± 81.5
- OG003
|
|
| |
| Primary | AUC Assessed for Docosahexaenoic Acids (DHA) After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (μg*h/mL) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. | | OG002 |
|
| Primary | AUC Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (nmol*hr/mL) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. | |
|
| Primary | 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. | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (μg*h/mL) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. |
|
| Primary | AUC (0-72) Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (μg*h/mL) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. | | OG002 |
|
| Primary | AUC (0-72) Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (nmol*hr/mL) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. | |
|
| Primary | Maximum Observed Plasma Concentration (Cmax) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (μg/mL) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. | |
|
| Primary | Cmax Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (μg/mL) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. | | OG002 |
|
| Primary | Cmax Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (nmol/mL) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. | |
|
| Secondary | 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. | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (μg*h/mL) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. |
|
| Secondary | AUC (Last) Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (μg*h/mL) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. | |
|
| Secondary | AUC (Last) Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (nmol*hr/mL) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. |
|
| Secondary | Baseline Concentration (C0) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (μg/mL) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. | |
|
| Secondary | C0 Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (μg/mL) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. | |
|
| Secondary | C0 Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (nmol/mL) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. |
|
| Secondary | 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. | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (hour) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. |
|
| Secondary | t½λz Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (hour) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. | | OG002 |
|
| Secondary | t½λz Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (hour) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. | |
|
| Secondary | Time to Reach Maximum Observed Concentration (Tmax) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. | 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. | 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. | Posted | | Median | Full Range | (hour) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. | | OG002 |
|
| Secondary | Tmax Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. | 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. | 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. | Posted | | Median | Full Range | (hour) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. | | OG002 | Treatment C_Part 1 |
|
| Secondary | Tmax Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. | 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. | 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. | Posted | | Median | Full Range | (hour) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. | | OG002 |
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| Secondary | Terminal Elimination Rate Constant (λz ) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (1/hour) | | 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 | | | | ID | Title | Description |
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| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. | |
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| Secondary | λz Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (1/h) | | 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 | | | | ID | Title | Description |
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| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. | | OG002 |
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| Secondary | λz Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation. | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (1/h) | | 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 | | | | ID | Title | Description |
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| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. | |
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| Secondary | Safety of Omega-3-carboxylic Acids by Assessing Summary of Adverse Events | To assess the safety summary of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects | 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. | Posted | | Number | | Participants | | From screening (within 28 days of first dosing) up to 14 days after last dosing | | | | ID | Title | Description |
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| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. | | OG002 | Treatment C_Part 1 | Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions. | | OG003 | Treatment D_Part 1 |
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| Secondary | Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event | 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 | 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. | Posted | | Number | | Partcipants | | From screening (within 28 days of first dosing) up to 14 days after last dosing. | | | | ID | Title | Description |
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| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. | | OG002 | Treatment C_Part 1 | Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions. | |
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| Secondary | Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Blood Pressure | 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 | 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. | Posted | | Number | | Participants | | From screening (within 28 days of first dosing) up to 14 days after last dosing | | | | ID | Title | Description |
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| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. | | OG002 | Treatment C_Part 1 | Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions. |
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| Secondary | Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Pulse | 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 | 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. | Posted | | Number | | Participants | | From screening (within 28 days of first dosing) up to 14 days after last dosing | | | | ID | Title | Description |
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| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. | | OG002 | Treatment C_Part 1 | Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions. | |
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| Secondary | Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant 12-lead Electrocardiograms (ECGs) | 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 | 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. | Posted | | Number | | Participants | | From screening (within 28 days of first dosing) up to 14 days after last dosing | | | | ID | Title | Description |
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| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. | | OG002 | Treatment C_Part 1 | Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions. |
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| Secondary | Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Hematology Parameters | 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 | 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. | Posted | | Number | | Participants | | From screening (within 28 days of first dosing) up to 14 days after last dosing | | | | ID | Title | Description |
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| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. | | OG002 | Treatment C_Part 1 | Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions. |
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| Secondary | Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Clinical Chemistry Laboratory Results | 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 | 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. | Posted | | Number | | Participants | | From screening (within 28 days of first dosing) up to 14 days after last dosing | | | | ID | Title | Description |
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| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. | | OG002 | Treatment C_Part 1 | Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions. |
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| Secondary | Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Urinalysis | 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 | 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. | Posted | | Number | | Participants | | From screening (within 28 days of first dosing) up to 14 days after last dosing | | | | ID | Title | Description |
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| OG000 | Treatment A_Part 1 | Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition. | | OG001 | Treatment B_Part 1 | Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition. | | OG002 | Treatment C_Part 1 | Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions. |
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