Comparison of Two KADIAN 10 mg Capsules to a KADIAN 20 mg Capsule Under Fasted Conditions

This study has been completed.
Sponsor:
Information provided by:
Actavis Inc.
ClinicalTrials.gov Identifier:
NCT00759902
First received: September 24, 2008
Last updated: August 13, 2010
Last verified: August 2010
Results First Received: December 5, 2008  
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: morphine sulfate extended-release capsules
Drug: KADIAN (morphine sulfate extended-release) capsules

  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
Period 1: Treatment A or B Treatment A (test product) followed by Treatment B (reference product)
Period 2: Treatment A or B Treatment B (reference product) followed by Treatment A (test product)

Participant Flow:   Overall Study
    Period 1: Treatment A or B     Period 2: Treatment A or B  
STARTED     18     18  
COMPLETED     18     17  
NOT COMPLETED     0     1  
Adverse Event                 0                 1  



  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
Period 1: Treatment A or B Treatment A (test product) followed by Treatment B (reference product)
Period 2: Treatment A or B Treatment B (reference product) followed by Treatment A (test product)
Total Total of all reporting groups

Baseline Measures
    Period 1: Treatment A or B     Period 2: Treatment A or B     Total  
Number of Participants  
[units: participants]
  18     18     36  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     18     18     36  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  31.6  ± 9.6     31.7  ± 8.9     31.7  ± 9.2  
Gender  
[units: participants]
     
Female     10     10     20  
Male     8     8     16  
Region of Enrollment  
[units: participants]
     
United States     18     18     36  



  Outcome Measures
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1.  Primary:   Maximum Plasma Morphine Concentration   [ Time Frame: 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs ]

2.  Secondary:   Time of Maximum Plasma Morphine Concentration   [ Time Frame: 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs ]

3.  Secondary:   Area Under the Curve to the Last Measurable Time Point for Plasma Morphine   [ Time Frame: 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs ]

4.  Secondary:   Area Under the Curve to Infinity for Plasma Morphine   [ Time Frame: 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


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: Meena Venugopal, Director, Clinical R&D
Organization: Actavis Inc.
phone: 908-659-2885
e-mail: MVenugopal@actavis.com


No publications provided


Responsible Party: Meena Venugopal, Director, Clinical R&D, Actavis Inc
ClinicalTrials.gov Identifier: NCT00759902     History of Changes
Other Study ID Numbers: 20-073-SA
Study First Received: September 24, 2008
Results First Received: December 5, 2008
Last Updated: August 13, 2010
Health Authority: United States: Food and Drug Administration