Status:
COMPLETED
The Bioequivalence of Atripla in an Oral Liquid Formulation Compared With the Tablet Formulation in Healthy Volunteers
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Healthy
Eligibility:
All Genders
19-65 years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to determine the average bioequivalence of tenofovir, emtricitabine and efavirenz in an extemporaneously prepared oral liquid formulation (test formulation) comp...
Eligibility Criteria
Inclusion
- Age ≥19 and ≤65, HIV-1 negative, Able to give consent, Non-smoking,Screening EKG within normal limits, Females of childbearing potential must have a negative pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.
Exclusion
- Subjects receiving any prescription or over-the-counter products will be excluded from the study. Subjects using any form of recreational drugs will be excluded. Subjects who have any of the following laboratory abnormalities within 30 days of study entry will be excluded:
- SGOT (AST)/SGPT (ALT) \> 3 x upper limits of normal (ULN) (Subjects with liver disease are allowed to enroll unless their AST/ALT levels are greater than three times ULN)
- Bilirubin \> 2.5 x ULN
- Amylase \> 2 x ULN
- Absolute Neutrophil Count \< 1000 x 103/L
- Hgb \< 9.0 g/dl
- Platelets \<50,000 cells/mm3
- Serum Creatinine \> 2.5 mg/dl
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00862823
Start Date
February 1 2009
End Date
May 1 2010
Last Update
September 14 2012
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294