Single-Dose Bioequivalence of a new Fixed-Dose combination tablet containing Tenofovir Disoproxil Fumarate and Lamivudine.
F.P. Clinical Pharma, - Richmond Laboratories - Buenos Aires, Argentina.
Tenofovir Disoproxil Fumarate, CAS 147127-20-6 is a nucleotide reverse transcriptase inhibitor with potent activity against both HIV and hepatits B infections. Lamivudine, CAS 134678-17-4 is a nucleoside analogue reverse transcriptase inhibitor developed as a treatment for HIV infection and also with activity against hepatitis B virus. The combination of tenofovir and lamibudine associated either with non-nucleoside reverse transcriptase inhibitors or with a ritonavir-boosted or unboosted protease inhibitor are recomended as preferred regimens for antiretroviral therapy-naive patients infected with HIV, and also for the treatment of HIV-HVB coinfected patients. The objetive of this study was to compare rate and extent of absorption and to assess the bioequivalence between a new pharmaceutical equivalent tablet formulation containing a fixed-dose combination of tenofovir disoproxil fumarate / lamivudine 300 / 300 mg and the innovator products.