Trial Outcomes & Findings for Fasted Pharmacokinetic and Bioequivalency Study of Fenofibric Acid (NCT NCT00961259)
NCT ID: NCT00961259
Last Updated: 2012-06-08
Results Overview
The maximum or peak concentration that the drug reaches in the plasma. For the dosing group, Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg), the Cmax values were dose-adjusted in order to assess pharmacokinetic linearity.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
54 participants
Primary outcome timeframe
serial pharmacokinetic blood samples drawn immediately prior to dosing and then 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 dose administration
Results posted on
2012-06-08
Participant Flow
Fifty-Four (54) non-obese, non-smoking, healthy adult volunteers from the community at large were enrolled.
One hundred and eight (108) subjects were screened. Thirty-six (36) subjects were screen failures. Of the remaining seventy-two (72) subjects, fifty-six (56) checked in and fifty-four (54) were enrolled.
Participant milestones
| Measure |
Treatment Sequence ABC
On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received one 35 mg fenofibric acid tablet (treatment A). After a 7 day washout period, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received three 35 mg fenofibric acid tablets (treatment B). After a 7 day washout period, on the morning of Day 15 after an overnight fast of at least 10 hours, each subject received one 105 mg fenofibric acid tablet (treatment C).
|
Treatment Sequence BCA
On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received three 35 mg fenofibric acid tablets (105 mg total dose, treatment B). After a 7 day washout period, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received one 105 mg fenofibric acid tablet (treatment C). After a 7 day washout period, on the morning of Day 15 after an overnight fast of at least 10 hours, each subject received one 35 mg fenofibric acid tablet (treatment A).
|
Treatment Sequence CAB
On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received one 105 mg fenofibric acid tablet (treatment C). After a 7 day washout period, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received one 35 mg fenofibric acid tablet (treatment A). After a 7 day washout period, on the morning of Day 15 after an overnight fast of at least 10 hours, each subject received three 35 mg fenofibric acid tablets (105 mg total dose, treatment B).
|
|---|---|---|---|
|
First Intervention
STARTED
|
18
|
18
|
18
|
|
First Intervention
COMPLETED
|
18
|
18
|
18
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout Period of 7 Days
STARTED
|
18
|
17
|
18
|
|
Washout Period of 7 Days
COMPLETED
|
18
|
17
|
18
|
|
Washout Period of 7 Days
NOT COMPLETED
|
0
|
0
|
0
|
|
Second Intervention
STARTED
|
18
|
17
|
18
|
|
Second Intervention
COMPLETED
|
18
|
17
|
18
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
0
|
|
Third Intervention
STARTED
|
18
|
17
|
18
|
|
Third Intervention
COMPLETED
|
18
|
17
|
18
|
|
Third Intervention
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment Sequence ABC
On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received one 35 mg fenofibric acid tablet (treatment A). After a 7 day washout period, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received three 35 mg fenofibric acid tablets (treatment B). After a 7 day washout period, on the morning of Day 15 after an overnight fast of at least 10 hours, each subject received one 105 mg fenofibric acid tablet (treatment C).
|
Treatment Sequence BCA
On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received three 35 mg fenofibric acid tablets (105 mg total dose, treatment B). After a 7 day washout period, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received one 105 mg fenofibric acid tablet (treatment C). After a 7 day washout period, on the morning of Day 15 after an overnight fast of at least 10 hours, each subject received one 35 mg fenofibric acid tablet (treatment A).
|
Treatment Sequence CAB
On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received one 105 mg fenofibric acid tablet (treatment C). After a 7 day washout period, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received one 35 mg fenofibric acid tablet (treatment A). After a 7 day washout period, on the morning of Day 15 after an overnight fast of at least 10 hours, each subject received three 35 mg fenofibric acid tablets (105 mg total dose, treatment B).
|
|---|---|---|---|
|
Washout Period of 7 Days
due to concomitant medication used
|
0
|
1
|
0
|
Baseline Characteristics
Fasted Pharmacokinetic and Bioequivalency Study of Fenofibric Acid
Baseline characteristics by cohort
| Measure |
Fenofibric Acid - Treatments A, B and C
n=54 Participants
All subjects received each of the three study regimens in a randomly assigned sequence of dosing periods. On the mornings of Days 1, 8 and 15 each subject received either one 35 mg fenofibric acid tablet (treatment A), three 35 mg fenofibric acid tablets (105 mg total dose, treatment B) or one 105 mg fenofibric acid tablet (treatment C).
|
|---|---|
|
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
|
24.46 years
STANDARD_DEVIATION 7.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 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
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
46 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 blood samples drawn immediately prior to dosing and then 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 dose administrationPopulation: Pharmacokinetic analyses of fenofibric acid are based on 53 out of the 54 subjects who completed the study.
The maximum or peak concentration that the drug reaches in the plasma. For the dosing group, Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg), the Cmax values were dose-adjusted in order to assess pharmacokinetic linearity.
Outcome measures
| Measure |
Fenofibric Acid 35 mg (1 x 35 mg Tablet) - Treatment A
n=53 Participants
Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
|
Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg)
n=53 Participants
Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
|
Fenofibric Acid 105 mg (3 x 35 mg Tablet) - Treatment B
n=53 Participants
Each subject received three tablets of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
|
Fenofibric Acid 105 mg (1 x 105 mg Tablet) - Treatment C
n=53 Participants
Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
3,569.47 ng/mL
Standard Deviation 685.12
|
10,708.40 ng/mL
Standard Deviation 2,055.36
|
11,014.93 ng/mL
Standard Deviation 2,033.94
|
11,202.87 ng/mL
Standard Deviation 2,470.61
|
PRIMARY outcome
Timeframe: serial pharmacokinetic blood samples drawn immediately prior to dosing and then 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 dose administrationPopulation: Pharmacokinetic analyses of fenofibric acid are based on 53 out of the 54 subjects who completed the 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. For the dosing group, Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg), the \[AUC(0-t)\] values were dose-adjusted in order to assess pharmacokinetic linearity.
Outcome measures
| Measure |
Fenofibric Acid 35 mg (1 x 35 mg Tablet) - Treatment A
n=53 Participants
Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
|
Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg)
n=53 Participants
Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
|
Fenofibric Acid 105 mg (3 x 35 mg Tablet) - Treatment B
n=53 Participants
Each subject received three tablets of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
|
Fenofibric Acid 105 mg (1 x 105 mg Tablet) - Treatment C
n=53 Participants
Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
|
49,419.89 ng-hr/mL
Standard Deviation 18,188.17
|
148,259.66 ng-hr/mL
Standard Deviation 54,564.52
|
131,976.95 ng-hr/mL
Standard Deviation 41,086.74
|
135,119.10 ng-hr/mL
Standard Deviation 42,326.25
|
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 of fenofibric acid are based on 53 out of the 54 subjects who completed the 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. For the dosing group, Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg), the AUC(0-∞) values were dose-adjusted in order to assess pharmacokinetic linearity.
Outcome measures
| Measure |
Fenofibric Acid 35 mg (1 x 35 mg Tablet) - Treatment A
n=53 Participants
Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
|
Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg)
n=53 Participants
Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
|
Fenofibric Acid 105 mg (3 x 35 mg Tablet) - Treatment B
n=53 Participants
Each subject received three tablets of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
|
Fenofibric Acid 105 mg (1 x 105 mg Tablet) - Treatment C
n=53 Participants
Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)
|
58,304.35 ng-hr/mL
Standard Deviation 20,877.56
|
174,913.04 ng-hr/mL
Standard Deviation 62,632.68
|
142,858.88 ng-hr/mL
Standard Deviation 45,554.44
|
147,555.58 ng-hr/mL
Standard Deviation 48,994.99
|
Adverse Events
Fenofibric Acid 35 mg (1 x 35 mg Tablet), Treatment A
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Fenofibric Acid 105 mg (3 x 35 mg Tablet), Treatment B
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Fenofibric Acid 105 mg (1 x 105 mg Tablet), Treatment C
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 35 mg (1 x 35 mg Tablet), Treatment A
n=53 participants at risk
Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
|
Fenofibric Acid 105 mg (3 x 35 mg Tablet), Treatment B
n=54 participants at risk
Each subject received three (3) tablets of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
|
Fenofibric Acid 105 mg (1 x 105 mg Tablet), Treatment C
n=53 participants at risk
Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
|
|---|---|---|---|
|
Eye disorders
Eye irritation
|
1.9%
1/53 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
0.00%
0/54
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
0.00%
0/53
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/53
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
0.00%
0/54
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
1.9%
1/53 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/53
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
1.9%
1/54 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
0.00%
0/53
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/53
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
0.00%
0/54
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
1.9%
1/53 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
|
General disorders
Fatigue
|
0.00%
0/53
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
1.9%
1/54 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
0.00%
0/53
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
|
General disorders
Vessel puncture site hematoma
|
1.9%
1/53 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
0.00%
0/54
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
0.00%
0/53
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/53
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
0.00%
0/54
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
1.9%
1/53 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
|
Injury, poisoning and procedural complications
Orthodontic appliance complication
|
1.9%
1/53 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
0.00%
0/54
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
0.00%
0/53
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
|
Nervous system disorders
Headache
|
3.8%
2/53 • Number of events 2
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
0.00%
0/54
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
3.8%
2/53 • Number of events 2
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
1/53 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
0.00%
0/54
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
0.00%
0/53
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/53
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
3.7%
2/54 • Number of events 2
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
0.00%
0/53
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.9%
1/53 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
1.9%
1/54 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
1.9%
1/53 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/53
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
0.00%
0/54
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
1.9%
1/53 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
1/53 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
0.00%
0/54
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
|
0.00%
0/53
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60