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Triomune Bioequivalence With Innovators

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ClinicalTrials.gov Identifier: NCT01025830
Recruitment Status : Completed
First Posted : December 4, 2009
Results First Posted : December 4, 2009
Last Update Posted : January 5, 2010
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by:
Makerere University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV/AIDS
Interventions: Drug: Triomune
Drug: Zerit/Epivir/Viramune

  Participant Flow


  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
Entire Study Population Includes groups randomized to receive generic formulation and brand formulation

Baseline Measures
   Entire Study Population 
Overall Participants Analyzed 
[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

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 ]

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 ]


  Serious Adverse Events


  Other Adverse Events


  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
Stavudine (40mg) was used whereas currently it is Stavudine(30mg) that is recommended for usage. So our results may not be applicable to patients on Stavudine 30mg.


  More Information