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M Menning
M Menning
Tanzania
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Research Article
Bioequivalence of the Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Single Tablet Regimen
Author(s): Anita Mathias, M Menning, L Wiser, X Wei, A Dave, S Chuck and BP KearneyAnita Mathias, M Menning, L Wiser, X Wei, A Dave, S Chuck and BP Kearney
Emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) is a next-generation, once-daily complete antiretroviral single-tablet regimen for the treatment of HIV-1 infection in adults. This study evaluated the pharmacokinetics and bioequivalence of 2 distinct investigational coformulations of the FTC/RPV/TDF single-tablet regimen (containing emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir disoproxil fumarate 300 mg) compared with the concurrent administration of a 200-mg strength capsule of FTC, a 25-mg strength tablet of RPV, and a 300-mg strength tablet of tenofovir disoproxil fumarate in healthy subjects. Thirty-six subjects were randomized in a single-dose, open-label, 3-way crossover study design; 34 subjects completed all study treatments. Serial blood samples were obtained over 192 hours following oral administration of each treatment and pharmacokinet.. View More»
DOI: 10.4172/jbb.1000121