Trial Outcomes & Findings for Fed Bioequivalence Study of Fenofibric Acid Versus TriCor® (Fenofibrate) (NCT NCT00960687)
NCT ID: NCT00960687
Last Updated: 2009-10-20
Results Overview
The maximum or peak concentration that the drug reaches in the plasma.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
54 participants
Primary outcome timeframe
serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.
Results posted on
2009-10-20
Participant Flow
Fifty-Four (54) non-obese, non-smoking, healthy adult volunteers, consisting of members of the community-at-large, were enrolled.
Ninety-nine (99) subjects were screened. Forty-five (45) subjects were screen failures. The remaining fifty-four subjects were enrolled, 47 of whom completed the study.
Participant milestones
| Measure |
Fenofibric Acid 105 mg Tablets Then Fenofibrate 145 mg Tablets
On the morning of Day 1 subjects received one tablet of the test formulation, fenofibric acid 105 mg, 30 minutes after the initiation of a standard breakfast, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, fenofibrate 145 mg, 30 minutes after the initiation of a standard breakfast.
|
Fenofibrate 145 mg Tablets Then Fenofibric Acid 105 mg Tablets
On the morning of Day 1 subjects received one tablet of the reference formulation, fenofibrate 145 mg, 30 minutes after the initiation of a standard breakfast, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, fenofibric acid 105 mg, 30 minutes after the initiation of a standard breakfast.
|
|---|---|---|
|
First Intervention
STARTED
|
27
|
27
|
|
First Intervention
COMPLETED
|
27
|
27
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout Period of 7 Days
STARTED
|
27
|
27
|
|
Washout Period of 7 Days
COMPLETED
|
23
|
24
|
|
Washout Period of 7 Days
NOT COMPLETED
|
4
|
3
|
|
Second Intervention
STARTED
|
23
|
24
|
|
Second Intervention
COMPLETED
|
23
|
24
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Fenofibric Acid 105 mg Tablets Then Fenofibrate 145 mg Tablets
On the morning of Day 1 subjects received one tablet of the test formulation, fenofibric acid 105 mg, 30 minutes after the initiation of a standard breakfast, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, fenofibrate 145 mg, 30 minutes after the initiation of a standard breakfast.
|
Fenofibrate 145 mg Tablets Then Fenofibric Acid 105 mg Tablets
On the morning of Day 1 subjects received one tablet of the reference formulation, fenofibrate 145 mg, 30 minutes after the initiation of a standard breakfast, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, fenofibric acid 105 mg, 30 minutes after the initiation of a standard breakfast.
|
|---|---|---|
|
Washout Period of 7 Days
Adverse Event
|
3
|
2
|
|
Washout Period of 7 Days
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Fed Bioequivalence Study of Fenofibric Acid Versus TriCor® (Fenofibrate)
Baseline characteristics by cohort
| Measure |
Fenofibric Acid 105 mg Tablets and Fenofibrate 145 mg Tablets
n=54 Participants
All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either fenofibric acid 105 mg or fenofibrate 145 mg, 30 minutes after the initiation of a standard meal.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
54 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
24.4 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.Population: Pharmacokinetic analyses are based on 47 out of 54 enrolled subjects who completed this study.
The maximum or peak concentration that the drug reaches in the plasma.
Outcome measures
| Measure |
Fenofibric Acid 105 mg Tablets
n=47 Participants
Each subject received one tablet of fenofibric acid 105mg 30 minutes after the initiation of a standard breakfast.
|
Fenofibrate 145 mg Tablets
n=47 Participants
Each subject received one tablet of fenofibrate 145mg 30 minutes after the initiation of a standard breakfast.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
8,545.50 ng/mL
Standard Deviation 1,792.62
|
9,456.66 ng/mL
Standard Deviation 1,741.55
|
PRIMARY outcome
Timeframe: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.Population: Pharmacokinetic analyses are based on 47 out of 54 enrolled subjects who completed this study.
The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.
Outcome measures
| Measure |
Fenofibric Acid 105 mg Tablets
n=47 Participants
Each subject received one tablet of fenofibric acid 105mg 30 minutes after the initiation of a standard breakfast.
|
Fenofibrate 145 mg Tablets
n=47 Participants
Each subject received one tablet of fenofibrate 145mg 30 minutes after the initiation of a standard breakfast.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
|
121,974.07 ng-hr/mL
Standard Deviation 46,243.60
|
132,463.37 ng-hr/mL
Standard Deviation 48,121.11
|
PRIMARY outcome
Timeframe: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.Population: Pharmacokinetic analyses are based on 47 out of 54 enrolled subjects who completed this study.
The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.
Outcome measures
| Measure |
Fenofibric Acid 105 mg Tablets
n=47 Participants
Each subject received one tablet of fenofibric acid 105mg 30 minutes after the initiation of a standard breakfast.
|
Fenofibrate 145 mg Tablets
n=47 Participants
Each subject received one tablet of fenofibrate 145mg 30 minutes after the initiation of a standard breakfast.
|
|---|---|---|
|
The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)
|
134,576.33 ng-hr/mL
Standard Deviation 52,676.64
|
146,847.53 ng-hr/mL
Standard Deviation 54,588.94
|
Adverse Events
Fenofibric Acid 105 mg Tablets
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Fenofibrate 145 mg Tablets
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fenofibric Acid 105 mg Tablets
n=51 participants at risk
Each subject received one tablet of fenofibric acid 105 mg 30 minutes after the initiation of a standard breakfast.
|
Fenofibrate 145 mg Tablets
n=50 participants at risk
Each subject received one tablet of fenofibrate 145 mg 30 minutes after the initiation of a standard breakfast.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/51
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 51 subjects were administered Fenofibric Acid 105 mg tablets. 50 subjects were administered Fenofibrate 145 mg tablets.
|
2.0%
1/50 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 51 subjects were administered Fenofibric Acid 105 mg tablets. 50 subjects were administered Fenofibrate 145 mg tablets.
|
|
General disorders
Feeling hot
|
0.00%
0/51
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 51 subjects were administered Fenofibric Acid 105 mg tablets. 50 subjects were administered Fenofibrate 145 mg tablets.
|
2.0%
1/50 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 51 subjects were administered Fenofibric Acid 105 mg tablets. 50 subjects were administered Fenofibrate 145 mg tablets.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/51
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 51 subjects were administered Fenofibric Acid 105 mg tablets. 50 subjects were administered Fenofibrate 145 mg tablets.
|
2.0%
1/50 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 51 subjects were administered Fenofibric Acid 105 mg tablets. 50 subjects were administered Fenofibrate 145 mg tablets.
|
|
Investigations
Aspartate aminotransferase increased
|
2.0%
1/51 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 51 subjects were administered Fenofibric Acid 105 mg tablets. 50 subjects were administered Fenofibrate 145 mg tablets.
|
0.00%
0/50
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 51 subjects were administered Fenofibric Acid 105 mg tablets. 50 subjects were administered Fenofibrate 145 mg tablets.
|
|
Investigations
Blood creatine phosphokinase increased
|
5.9%
3/51 • Number of events 3
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 51 subjects were administered Fenofibric Acid 105 mg tablets. 50 subjects were administered Fenofibrate 145 mg tablets.
|
2.0%
1/50 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 51 subjects were administered Fenofibric Acid 105 mg tablets. 50 subjects were administered Fenofibrate 145 mg tablets.
|
|
Investigations
Heart rate increased
|
2.0%
1/51 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 51 subjects were administered Fenofibric Acid 105 mg tablets. 50 subjects were administered Fenofibrate 145 mg tablets.
|
0.00%
0/50
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 51 subjects were administered Fenofibric Acid 105 mg tablets. 50 subjects were administered Fenofibrate 145 mg tablets.
|
|
Investigations
White blood cell count increased
|
0.00%
0/51
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 51 subjects were administered Fenofibric Acid 105 mg tablets. 50 subjects were administered Fenofibrate 145 mg tablets.
|
2.0%
1/50 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 51 subjects were administered Fenofibric Acid 105 mg tablets. 50 subjects were administered Fenofibrate 145 mg tablets.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.0%
1/51 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 51 subjects were administered Fenofibric Acid 105 mg tablets. 50 subjects were administered Fenofibrate 145 mg tablets.
|
0.00%
0/50
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 51 subjects were administered Fenofibric Acid 105 mg tablets. 50 subjects were administered Fenofibrate 145 mg tablets.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
1/51 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 51 subjects were administered Fenofibric Acid 105 mg tablets. 50 subjects were administered Fenofibrate 145 mg tablets.
|
0.00%
0/50
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 51 subjects were administered Fenofibric Acid 105 mg tablets. 50 subjects were administered Fenofibrate 145 mg tablets.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/51
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 51 subjects were administered Fenofibric Acid 105 mg tablets. 50 subjects were administered Fenofibrate 145 mg tablets.
|
2.0%
1/50 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 51 subjects were administered Fenofibric Acid 105 mg tablets. 50 subjects were administered Fenofibrate 145 mg tablets.
|
|
Nervous system disorders
Dizziness
|
3.9%
2/51 • Number of events 2
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 51 subjects were administered Fenofibric Acid 105 mg tablets. 50 subjects were administered Fenofibrate 145 mg tablets.
|
4.0%
2/50 • Number of events 2
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 51 subjects were administered Fenofibric Acid 105 mg tablets. 50 subjects were administered Fenofibrate 145 mg tablets.
|
|
Nervous system disorders
Headache
|
0.00%
0/51
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 51 subjects were administered Fenofibric Acid 105 mg tablets. 50 subjects were administered Fenofibrate 145 mg tablets.
|
4.0%
2/50 • Number of events 2
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 51 subjects were administered Fenofibric Acid 105 mg tablets. 50 subjects were administered Fenofibrate 145 mg tablets.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60