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Bioequivalence Study of Colchicine Tablets

This study has been completed.
Sponsor:
Information provided by:
Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:
NCT01021020
First received: August 12, 2009
Last updated: December 1, 2009
Last verified: December 2009
Results First Received: August 12, 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: Colchicine
Drug: Colchicine/Probenecid

  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
Twenty-eight (28) healthy, non-smoking, adult male and female volunteers, consisting of university students and members of the community at large, were to be enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
75 subjects screened, 47 were screen failures

Reporting Groups
  Description
Colchicine (Fasted),Colchicine (Fed),Colchicine/Probenecid All subjects received each of the three study treatments in a randomly assigned sequence of dosing periods. On the morning of Days 1, 15, and 29, each subject received one of the following three treatments: 1) one tablet of colchicine 0.6 mg after an overnight fast of at least 13.5 hours, 2) one tablet of colchicine 0.6 mg after a high-fat breakfast, or 3) one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast of at least 13.5 hours.

Participant Flow for 5 periods

Period 1:   Period I
    Colchicine (Fasted),Colchicine (Fed),Colchicine/Probenecid  
STARTED     28  
COMPLETED     26 [1]
NOT COMPLETED     2  
Protocol Violation                 1  
Withdrawal by Subject                 1  
[1] Colchicine(fasted)-subject took Claritin-D 12hour.Colchicine(fed)arm-subject had schedule conflict.

Period 2:   14 Day Washout Period A
    Colchicine (Fasted),Colchicine (Fed),Colchicine/Probenecid  
STARTED     26  
COMPLETED     25 [1]
NOT COMPLETED     1  
Physician Decision                 1  
[1] Colchicine/Probenecid-medical investigator dropped due to abnormal check-in lab results.

Period 3:   Period II
    Colchicine (Fasted),Colchicine (Fed),Colchicine/Probenecid  
STARTED     25  
COMPLETED     25  
NOT COMPLETED     0  

Period 4:   14 Day Washout Period B
    Colchicine (Fasted),Colchicine (Fed),Colchicine/Probenecid  
STARTED     25  
COMPLETED     25  
NOT COMPLETED     0  

Period 5:   Period III
    Colchicine (Fasted),Colchicine (Fed),Colchicine/Probenecid  
STARTED     25  
COMPLETED     25  
NOT COMPLETED     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
Colchicine(Fasted),Colchicine(Fed),Colchicine/Probenecid All subjects received all study treatments in a randomly assigned sequence of dosing periods. On the morning of Days 1, 15, and 29, each subject received one of the following three treatments: 1) one tablet of colchicine 0.6 mg after an overnight fast of at least 13.5 hours, 2) one tablet of colchicine 0.6 mg after a high-fat breakfast, or 3) one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast of at least 13.5 hours.

Baseline Measures
    Colchicine(Fasted),Colchicine(Fed),Colchicine/Probenecid  
Number of Participants  
[units: participants]
  28  
Age [1]
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     28  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  23.7  ± 5.7  
Gender  
[units: participants]
 
Female     18  
Male     10  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     1  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     2  
White     24  
More than one race     0  
Unknown or Not Reported     1  
Region of Enrollment  
[units: participants]
 
United States     28  
[1] age range: >=18 and <=45 years old



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximal Plasma Concentration (Cmax)   [ Time Frame: serial pharmacokinetic blood samples collected pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose ]

2.  Primary:   Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]   [ Time Frame: serial pharmacokinetic blood samples collected pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose ]

3.  Primary:   Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]   [ Time Frame: serial pharmacokinetic blood samples collected pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose ]


  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
No text entered.


  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 Affairs 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: NCT01021020     History of Changes
Other Study ID Numbers: MPC-004-07-1001
Study First Received: August 12, 2009
Results First Received: August 12, 2009
Last Updated: December 1, 2009
Health Authority: United States: Food and Drug Administration