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Triomune Bioequivalence With Innovators

This study has been completed.
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by:
Makerere University
ClinicalTrials.gov Identifier:
NCT01025830
First received: April 21, 2009
Last updated: December 31, 2009
Last verified: December 2009
History of Changes
Results First Received: April 21, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV/AIDS
Interventions: Drug: Triomune
Drug: Zerit/Epivir/Viramune

  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
Subjects were recruited from an ongoing cohort study in Kampala, Uganda. The first subject was recruited in Feb 2006.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants received a medical and laboratory examination before assignment. Subjects were excluded if they had active tuberculosis or were anemic. 22 participants were recruited; 22 were screened,2 were excluded (1 did not meet inclusion criteria and 1 refused participation).

Reporting Groups
  Description
Generic (Triomune) to Brand (Zerit/Epivir/Viramune) Started with generic formulation (Triomune) then switched to brand formulation (Zerit/Epivir/Viramune).
Brand (Zerit/Epivir/Viramune) to Generic (Triomune) started with brand formulation(Zerit/Epivir/Viramune) then switched to generic formulation (Triomune)

Participant Flow for 3 periods

 Period 1:   Generic (Tr) First Then Brand (Ze/Ep/Vi)
    Generic (Triomune) to Brand (Zerit/Epivir/Viramune)     Brand (Zerit/Epivir/Viramune) to Generic (Triomune)  
STARTED     8     12  
COMPLETED     8     12  
NOT COMPLETED     0     0  

Period 2:   Washout Period of 30 Days
    Generic (Triomune) to Brand (Zerit/Epivir/Viramune)     Brand (Zerit/Epivir/Viramune) to Generic (Triomune)  
STARTED     8     12  
COMPLETED     8     12  
NOT COMPLETED     0     0  

Period 3:   Brand (Ze/Ep/Vi) First Then Generic (Tr)
    Generic (Triomune) to Brand (Zerit/Epivir/Viramune)     Brand (Zerit/Epivir/Viramune) to Generic (Triomune)  
STARTED     8     12  
COMPLETED     8     12  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Entire Study Population Includes groups randomized to receive generic formulation and brand formulation

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
 		  20  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     20  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  37.4  ± 6.0  
Gender  
[units: participants]
 		 
Female     12  
Male     8  
Body Mass Index  
[units: kg/m2]
Mean ± Standard Deviation 		  25.1  ± 3.4  
Weight  
[units: kg]
Mean ± Standard Deviation 		  68.3  ± 6.6  



  Outcome Measures
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1.  Primary:   Area Under the Concentration-Time Curve(AUC)   [ Time Frame: Assessed at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 10 and 12 hr post-dosing ]
  Show Outcome Measure 1

2.  Secondary:   Maximum Plasma Concentration of Drug   [ Time Frame: Assessed at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 10 and 12 hr post-dosing ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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