Bioequivalence Study of Fenofibric Acid Versus Tricor® (Fenofibrate)

This study has been completed.
Sponsor:
Information provided by:
Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:
NCT00961116
First received: August 14, 2009
Last updated: October 27, 2009
Last verified: October 2009
Results First Received: August 24, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Healthy
Interventions: Drug: Fenofibric Acid (Fibricor™) 105 mg Tablet
Drug: Fenofibrate (Tricor®) 145 mg Tablet

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Fifty-four (54) non-obese, non-smoking, healthy adult volunteers, consisting of members of the community-at-large, were enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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 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.
Fenofibrate 145 mg Tablets Then Fenofibric Acid 105 mg Tablets 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.

Participant Flow for 3 periods

Period 1:   First Intervention
    Fenofibric Acid 105 mg Tablets Then Fenofibrate 145 mg Tablets     Fenofibrate 145 mg Tablets Then Fenofibric Acid 105 mg Tablets  
STARTED     27     27  
COMPLETED     27     27  
NOT COMPLETED     0     0  

Period 2:   Washout Period of 7 Days
    Fenofibric Acid 105 mg Tablets Then Fenofibrate 145 mg Tablets     Fenofibrate 145 mg Tablets Then Fenofibric Acid 105 mg Tablets  
STARTED     27     27  
COMPLETED     25     24  
NOT COMPLETED     2     3  
Adverse Event                 1                 1  
Withdrawal by Subject                 1                 1  
Protocol Violation                 0                 1  

Period 3:   Second Intervention
    Fenofibric Acid 105 mg Tablets Then Fenofibrate 145 mg Tablets     Fenofibrate 145 mg Tablets Then Fenofibric Acid 105 mg Tablets  
STARTED     25     24  
COMPLETED     25     24  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Fenofibric Acid 105 mg Tablets and Fenofibrate 145 mg Tablets 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.

Baseline Measures
    Fenofibric Acid 105 mg Tablets and Fenofibrate 145 mg Tablets  
Number of Participants  
[units: participants]
  54  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     54  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  23.7  ± 5.5  
Gender  
[units: participants]
 
Female     35  
Male     19  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     54  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     1  
Asian     2  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     1  
White     48  
More than one race     2  
Unknown or Not Reported     0  



  Outcome Measures
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1.  Primary:   Maximum Plasma Concentration (Cmax)   [ 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. ]

2.  Primary:   Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]   [ 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. ]

3.  Primary:   The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)   [ 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. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: clinicaltrials@urlmutual.com


No publications provided


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
Study First Received: August 14, 2009
Results First Received: August 24, 2009
Last Updated: October 27, 2009
Health Authority: United States: Food and Drug Administration