Objective: To evaluate the relative bioavailability of a new formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (T) and compare this formulation with the branded formulation (R) to meet regulatory criteria for marketing the test product in Argentina.
A randomized-sequence, open-label, two-period crossover study was conducted on 24 healthy Caucasian volunteers in a fasting state. A single oral dose of either T or R formulations was followed by a 7-day washout period. Blood samples were collected at baseline and 0.25, 0.50, 0.75, 1, 1.25, 1.5 2, 2.5, 3, 4, 7, 12, 24 and 48 h after administration. Emtricitabine and tenofovir concentrations were determined using a validated LC (liquid chromatography) - MS (mass spectrometry) / MS method. Adverse events were monitored based on clinical parameters and volunteer reports.
Two period administration of a formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg.
Capital Federal, Buenos Aires, Argentina