Trial Outcomes & Findings for Epanova® Compared to Lovaza® In a Pharmacokinetic, Single-dose, Evaluation (NCT NCT01208961)
NCT ID: NCT01208961
Last Updated: 2015-07-15
Results Overview
Analyses of the outcome measures presented are for baseline-adjusted data for total (esterified and unesterfied) EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation.
COMPLETED
PHASE2
54 participants
Blood samples were obtained pre-dose at -1.0, -0.5, and 0 hours and after dose administration at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours.
2015-07-15
Participant Flow
The enrollment period started October 2010 and the last subject visit was November 2010. All subjects were qualified at the clinical site and eligibility was determined by the PI (one US clinical site).
This was a 4-way crossover study with a minimum 7-day washout period between each treatment. Subjects were healthy volunteers aged ≥ 18 with a body mass index 25-35 kg/m2 and who were not intolerant to omega-3 products or fish. Subjects were instructed to follow the TLC diet and abstain from omega-3 products or fish for screening and all periods.
Participant milestones
| Measure |
Epanova-Lovaza-Epanova-Lovaza
Epanova (4 g) and Lovaza (4 g) : Single dose of Epanova (omefas; corresponds to omega-3 carboxylic acids), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Epanova (omefas), 4x1g capsules, taken with high-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters, 4x1g capsules, taken with high-fat meals
|
Lovaza-Epanova-Lovaza-Epanova
Lovaza (4 g) and Epanova (4 g) : Single dose of Lovaza (omega-3-acid ethyl esters), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Epanova (omefas; corresponds to omega-3 carboxylic acids), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters,4x1g capsules, taken with high-fat meals, 7 day washout followed by single dose of Epanova (omefas),4x1g capsules, taken with high-fat meals
|
|---|---|---|
|
Low-Fat Period I
STARTED
|
27
|
27
|
|
Low-Fat Period I
COMPLETED
|
27
|
27
|
|
Low-Fat Period I
NOT COMPLETED
|
0
|
0
|
|
Low-Fat Period II
STARTED
|
26
|
27
|
|
Low-Fat Period II
COMPLETED
|
26
|
27
|
|
Low-Fat Period II
NOT COMPLETED
|
0
|
0
|
|
High-Fat Period III
STARTED
|
26
|
26
|
|
High-Fat Period III
COMPLETED
|
25
|
26
|
|
High-Fat Period III
NOT COMPLETED
|
1
|
0
|
|
High-Fat Period IV
STARTED
|
25
|
26
|
|
High-Fat Period IV
COMPLETED
|
25
|
26
|
|
High-Fat Period IV
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Epanova-Lovaza-Epanova-Lovaza
Epanova (4 g) and Lovaza (4 g) : Single dose of Epanova (omefas; corresponds to omega-3 carboxylic acids), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Epanova (omefas), 4x1g capsules, taken with high-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters, 4x1g capsules, taken with high-fat meals
|
Lovaza-Epanova-Lovaza-Epanova
Lovaza (4 g) and Epanova (4 g) : Single dose of Lovaza (omega-3-acid ethyl esters), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Epanova (omefas; corresponds to omega-3 carboxylic acids), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters,4x1g capsules, taken with high-fat meals, 7 day washout followed by single dose of Epanova (omefas),4x1g capsules, taken with high-fat meals
|
|---|---|---|
|
High-Fat Period III
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Epanova® Compared to Lovaza® In a Pharmacokinetic, Single-dose, Evaluation
Baseline characteristics by cohort
| Measure |
All Subjects
n=54 Participants
All subjects received both Epanova (E) and Lovaza (L), and both under fasted and fed conditions. Subjects were randomized 1:1 to one of the following treatment period sequences: ELEL or LELE.
|
|---|---|
|
Age, Continuous
|
44.6 years
STANDARD_DEVIATION 11.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples were obtained pre-dose at -1.0, -0.5, and 0 hours and after dose administration at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours.Analyses of the outcome measures presented are for baseline-adjusted data for total (esterified and unesterfied) EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation.
Outcome measures
| Measure |
Epanova (Low-Fat Period)
n=51 Participants
Single dose of Epanova (omefas), 4\*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
|
Lovaza (Low-Fat Period)
n=51 Participants
Single dose of Lovaza (omega-3-acid ethyl esters), 4\*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
|
|---|---|---|
|
AUC(0-t): Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (the Final Time With a Concentration ≥ LOQ)
|
2650.1612 nmol.h/mL
Interval 689.2702 to 7883.479
|
661.9490 nmol.h/mL
Interval -603.7871 to 2967.316
|
PRIMARY outcome
Timeframe: Blood samples were obtained pre-dose at -1.0, -0.5, and 0 hours and after dose administration at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours.Analyses of the outcome measures presented are for baseline-adjusted data for total (esterified and unesterfied) EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation.
Outcome measures
| Measure |
Epanova (Low-Fat Period)
n=51 Participants
Single dose of Epanova (omefas), 4\*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
|
Lovaza (Low-Fat Period)
n=51 Participants
Single dose of Lovaza (omega-3-acid ethyl esters), 4\*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
|
|---|---|---|
|
AUC(Inf): Area Under the Plasma Concentration-time Curve From 0 to Infinity
|
5219.56 nmol.h/mL
Interval 1388.8324 to 13802.1423
|
803.42 nmol.h/mL
Interval 217.7803 to 2810.6873
|
PRIMARY outcome
Timeframe: Blood samples were obtained pre-dose at -1.0, -0.5, and 0 hours and after dose administration at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours.Analyses of the outcome measures presented are for baseline-adjusted data for total (esterified and unesterfied) EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation.
Outcome measures
| Measure |
Epanova (Low-Fat Period)
n=51 Participants
Single dose of Epanova (omefas), 4\*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
|
Lovaza (Low-Fat Period)
n=51 Participants
Single dose of Lovaza (omega-3-acid ethyl esters), 4\*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
|
|---|---|---|
|
C(Max): Maximum Plasma Concentration
|
225.7920 nmol/mL
Interval 38.7545 to 754.0992
|
61.0818 nmol/mL
Interval 21.082 to 843.7832
|
Adverse Events
All Subjects
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Subjects
n=54 participants at risk
All subjects received both Epanova (E) and Lovaza (L), and both under fasted and fed conditions. Subjects were randomized 1:1 to one of the following treatment period sequences: ELEL or LELE.
|
|---|---|
|
Infections and infestations
Diarrhoea
|
16.7%
9/54 • Number of events 10
The adverse event safety results were grouped and analyzed for the entire population since the OM-3 FFA and OM-3 EE treatments were single-dose administrations received by all subjects and the protocol was not developed as an exposure-response study design.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.4%
4/54 • Number of events 4
The adverse event safety results were grouped and analyzed for the entire population since the OM-3 FFA and OM-3 EE treatments were single-dose administrations received by all subjects and the protocol was not developed as an exposure-response study design.
|
|
Nervous system disorders
Dizziness
|
9.3%
5/54 • Number of events 5
The adverse event safety results were grouped and analyzed for the entire population since the OM-3 FFA and OM-3 EE treatments were single-dose administrations received by all subjects and the protocol was not developed as an exposure-response study design.
|
|
Nervous system disorders
Headache
|
18.5%
10/54 • Number of events 10
The adverse event safety results were grouped and analyzed for the entire population since the OM-3 FFA and OM-3 EE treatments were single-dose administrations received by all subjects and the protocol was not developed as an exposure-response study design.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Individual investigators may publish data arising from their own subjects. The PI will provide the Sponsor with copies of written publications (including abstracts and posters)at least 60 days in advance of submission. Data will be reviewed by all participating investigators prior to publication. The Sponsor will have 60 days to review all definitive publications, such as manuscripts and book chapters, and a minimum of 30 days to review all abstracts.
- Publication restrictions are in place
Restriction type: OTHER