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Bioequivalence Study of Fenofibric Acid Versus Tricor® (Fenofibrate)

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ClinicalTrials.gov Identifier: NCT00961116
Recruitment Status : Completed
First Posted : August 18, 2009
Results First Posted : October 1, 2009
Last Update Posted : November 3, 2009
Sponsor:
Information provided by:
Mutual Pharmaceutical Company, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy
Interventions Drug: Fenofibric Acid (Fibricor™) 105 mg Tablet
Drug: Fenofibrate (Tricor®) 145 mg Tablet
Enrollment 54
Recruitment Details Fifty-four (54) non-obese, non-smoking, healthy adult volunteers, consisting of members of the community-at-large, were enrolled.
Pre-assignment Details  
Arm/Group Title Fenofibric Acid 105 mg Tablets Then Fenofibrate 145 mg Tablets Fenofibrate 145 mg Tablets Then Fenofibric Acid 105 mg Tablets
Hide Arm/Group Description On the morning of Day 1 subjects received one tablet of the test formulation, fenofibric acid 105 mg after an overnight fast, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, fenofibrate 145 mg, after an overnight fast. On the morning of Day 1 subjects received one tablet of the reference, fenofibrate 145 mg after an overnight fast, 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, after an overnight fast.
Period Title: First Intervention
Started 27 27
Completed 27 27
Not Completed 0 0
Period Title: Washout Period of 7 Days
Started 27 27
Completed 25 24
Not Completed 2 3
Reason Not Completed
Adverse Event             1             1
Withdrawal by Subject             1             1
Protocol Violation             0             1
Period Title: Second Intervention
Started 25 24
Completed 25 24
Not Completed 0 0
Arm/Group Title Fenofibric Acid 105 mg Tablets and Fenofibrate 145 mg Tablets
Hide Arm/Group Description 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 following an overnight fast.
Overall Number of Baseline Participants 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
<=18 years
0
   0.0%
Between 18 and 65 years
54
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants
23.7  (5.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
Female
35
  64.8%
Male
19
  35.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
54
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
American Indian or Alaska Native
1
   1.9%
Asian
2
   3.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   1.9%
White
48
  88.9%
More than one race
2
   3.7%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Maximum Plasma Concentration (Cmax)
Hide Description The maximum or peak concentration that the drug reaches in the plasma.
Time Frame 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analyses are based on 49 out of 54 enrolled subjects who completed this study.
Arm/Group Title Fenofibric Acid 105 mg Tablets Fenofibrate 145 mg Tablets
Hide Arm/Group Description:
Each subject received one tablet of fenofibric acid 105mg after an overnight fast of at least 10 hours.
Each subject received one tablet of fenofibrate 145mg after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 49 49
Mean (Standard Deviation)
Unit of Measure: ng/mL
12,344.00  (3,032.94) 10,940.05  (2,576.52)
2.Primary Outcome
Title Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
Hide Description 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.
Time Frame 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analyses are based on 49 out of 54 enrolled subjects who completed this study.
Arm/Group Title Fenofibric Acid 105 mg Tablets Fenofibrate 145 mg Tablets
Hide Arm/Group Description:
Each subject received one tablet of fenofibric acid 105mg after an overnight fast of at least 10 hours.
Each subject received one tablet of fenofibrate 145 mg after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 49 49
Mean (Standard Deviation)
Unit of Measure: ng-hr/mL
159,866.23  (63,847.90) 170,727.10  (66,257.75)
3.Primary Outcome
Title The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)
Hide Description 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.
Time Frame 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analyses are based on 49 out of 54 enrolled subjects who completed this study.
Arm/Group Title Fenofibric Acid 105 mg Tablets Fenofibrate 145 mg Tablets
Hide Arm/Group Description:
Each subject received one tablet of fenofibric acid 105mg after an overnight fast of at least 10 hours.
Each subject received one tablet of fenofibrate 145mg after an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 49 49
Mean (Standard Deviation)
Unit of Measure: ng-hr/mL
176,816.78  (75,989.60) 188,331.49  (78,194.95)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fenofibric Acid 105 mg Tablets Fenofibrate 145 mg Tablets
Hide Arm/Group Description Each subject received one tablet of fenofibric acid 105 mg after an overnight fast of at least 10 hours. Each subject received one tablet of fenofibrate 145 mg after an overnight fast of at least 10 hours.
All-Cause Mortality
Fenofibric Acid 105 mg Tablets Fenofibrate 145 mg Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fenofibric Acid 105 mg Tablets Fenofibrate 145 mg Tablets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0      1    
Pregnancy, puerperium and perinatal conditions     
Miscarriage   0/35 (0.00%)  0 1/33 (3.03%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fenofibric Acid 105 mg Tablets Fenofibrate 145 mg Tablets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6      8    
Gastrointestinal disorders     
Diarrhea   1/51 (1.96%)  1 0/52 (0.00%)  0
Stomach Discomfort   1/51 (1.96%)  1 0/52 (0.00%)  0
Nausea   0/51 (0.00%)  0 1/52 (1.92%)  1
General disorders     
Feeling cold   0/51 (0.00%)  0 1/52 (1.92%)  1
Feeling hot   0/51 (0.00%)  0 1/52 (1.92%)  1
Vessel puncture site pain   0/51 (0.00%)  0 2/52 (3.85%)  2
Infections and infestations     
Skin bacterial infection   1/51 (1.96%)  1 0/52 (0.00%)  0
Investigations     
Blood human chorionic gonadotropin increased   0/51 (0.00%)  0 1/52 (1.92%)  1
Musculoskeletal and connective tissue disorders     
Back pain   0/51 (0.00%)  0 1/52 (1.92%)  1
Nervous system disorders     
Dizziness   0/51 (0.00%)  0 1/52 (1.92%)  1
Headache   4/51 (7.84%)  4 5/52 (9.62%)  5
Ulnar nerve palsy   0/51 (0.00%)  0 1/52 (1.92%)  1
Reproductive system and breast disorders     
Dysmennorrhea   0/51 (0.00%)  0 1/52 (1.92%)  1
Respiratory, thoracic and mediastinal disorders     
Dry throat   1/51 (1.96%)  1 1/52 (1.92%)  1
Pharyngolaryngeal pain   1/51 (1.96%)  1 0/52 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Medical Director
Organization: Mutual Pharmaceutical Company, Inc.
Phone: 215-697-1743
Responsible Party: Vice President, Branded products and Medical Affairs, Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier: NCT00961116     History of Changes
Other Study ID Numbers: MPC-028-07-1007
First Submitted: August 14, 2009
First Posted: August 18, 2009
Results First Submitted: August 24, 2009
Results First Posted: October 1, 2009
Last Update Posted: November 3, 2009