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Bioavailability Study of Colcrys® Crushed and Sprinkled on Applesauce

This study has been completed.
Sponsor:
Information provided by:
Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:
NCT01130051
First received: May 21, 2010
Last updated: May 10, 2011
Last verified: May 2011
History of Changes
Results First Received: April 5, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-availability Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Healthy
Intervention: Drug: Colchicine 0.6 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Colcrys® Intact Tab Then Colcrys® Sprinkled on Applesauce On the morning of Day 1, subjects received the reference formulation, one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours. Following a 14 day washout period, on the morning of Day 15, subjects received the test formulation, one Colcrys® 0.6 mg tablet crushed and sprinkled on applesauce, after an overnight fast of at least 10 hours
Colcrys® Sprinkled on Applesauce Then Colcrys® Intact Tab On the morning of Day 1 subjects received one tablet of the test formulation, Colcrys® 0.6 mg, crushed and sprinkled on applesauce, after an overnight fast of at least 10 hours. Following a 14 day washout period, on the morning of Day 15, subjects received one dose of the reference formulation, one intact Colcrys® 0.6 mg tablet, after an overnight fast of at least 10 hours

Participant Flow for 3 periods

 Period 1:   Period 1
    Colcrys® Intact Tab Then Colcrys® Sprinkled on Applesauce     Colcrys® Sprinkled on Applesauce Then Colcrys® Intact Tab  
STARTED     8     8  
COMPLETED     8     8  
NOT COMPLETED     0     0  

Period 2:   Washout Period of 14 Days
    Colcrys® Intact Tab Then Colcrys® Sprinkled on Applesauce     Colcrys® Sprinkled on Applesauce Then Colcrys® Intact Tab  
STARTED     8     8  
COMPLETED     7     6  
NOT COMPLETED     1     2  
Withdrawal by Subject                 0                 1  
Protocol Violation                 1                 1  

Period 3:   Period 2
    Colcrys® Intact Tab Then Colcrys® Sprinkled on Applesauce     Colcrys® Sprinkled on Applesauce Then Colcrys® Intact Tab  
STARTED     7     6  
COMPLETED     7     6  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Colcrys® Intact Tab and Colcrys® in Applesauce 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 15, each subject received one tablet of intact Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce, following an overnight fast of at least 10 hours.

Baseline Measures
    Colcrys® Intact Tab and Colcrys® in Applesauce  
Number of Participants  
[units: participants]
 		  16  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     16  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  37.812  ± 13.332  
Gender  
[units: participants]
 		 
Female     3  
Male     13  
Ethnicity (NIH/OMB)  
[units: participants]
 		 
Hispanic or Latino     3  
Not Hispanic or Latino     13  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 		 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     10  
White     4  
More than one race     0  
Unknown or Not Reported     2  
Region of Enrollment  
[units: participants]
 		 
United States     16  



  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 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration ]
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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 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration ]
  Show Outcome Measure 2

3.  Primary:   Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]   [ Time Frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


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.  


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: Medical Director, Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier: NCT01130051     History of Changes
Other Study ID Numbers: MPC-004-10-1002
Study First Received: May 21, 2010
Results First Received: April 5, 2011
Last Updated: May 10, 2011
Health Authority: United States: Institutional Review Board