Fasted Pharmacokinetic and Bioequivalency Study of Fenofibric Acid

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:
NCT00961259
First received: August 14, 2009
Last updated: June 1, 2012
Last verified: June 2012
Results First Received: August 20, 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 35 mg Tablet
Drug: Fenofibric Acid 105 mg Tablet

  Participant Flow
  Hide Participant Flow

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 from 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
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.

Reporting Groups
  Description
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).

Participant Flow for 5 periods

Period 1:   First Intervention
    Treatment Sequence ABC     Treatment Sequence BCA     Treatment Sequence CAB  
STARTED     18     18     18  
COMPLETED     18     18     18  
NOT COMPLETED     0     0     0  

Period 2:   Washout Period of 7 Days
    Treatment Sequence ABC     Treatment Sequence BCA     Treatment Sequence CAB  
STARTED     18     18     18  
COMPLETED     18     17 [1]   18  
NOT COMPLETED     0     1     0  
due to concomitant medication used                 0                 1                 0  
[1] dropped due to concomitant medication used prior to admission.

Period 3:   Second Intervention
    Treatment Sequence ABC     Treatment Sequence BCA     Treatment Sequence CAB  
STARTED     18     17     18  
COMPLETED     18     17     18  
NOT COMPLETED     0     0     0  

Period 4:   Washout Period of 7 Days
    Treatment Sequence ABC     Treatment Sequence BCA     Treatment Sequence CAB  
STARTED     18     17     18  
COMPLETED     18     17     18  
NOT COMPLETED     0     0     0  

Period 5:   Third Intervention
    Treatment Sequence ABC     Treatment Sequence BCA     Treatment Sequence CAB  
STARTED     18     17     18  
COMPLETED     18     17     18  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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 - Treatments A, B and C 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).

Baseline Measures
    Fenofibric Acid - Treatments A, B and C  
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
  24.46  ± 7.10  
Gender  
[units: participants]
 
Female     18  
Male     36  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     3  
Not Hispanic or Latino     51  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     2  
Asian     2  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     4  
White     46  
More than one race     0  
Unknown or Not Reported     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Plasma Concentration (Cmax)   [ Time Frame: 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 ]

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

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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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: Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier: NCT00961259     History of Changes
Other Study ID Numbers: MPC-028-08-1017, R08-0057
Study First Received: August 14, 2009
Results First Received: August 20, 2009
Last Updated: June 1, 2012
Health Authority: United States: Food and Drug Administration