Objective: To compare the bioavailability of 2 sertraline tablets formulations (Tolrest from Laboratorios Biosintetica, and Zoloft from Laboratorios Pfizer, Brazil) in 24 healthy volunteers of both sexes (12 male and 12 female) who received a single 50 mg dose of each sertraline formulation. Material and methods: The study was conducted open with randomized two-period crossover design and a 14-day washout period. Plasma samples were obtained over a 96-hour interval and sertraline concentrations were analyzed by combined reversed phase liquid chromatography and tandem mass spectrometry (LC-MS-MS) with positive ion electrospray ionization using selected ion monitoring method. From the plasma sertraline concentration vs. time curves the following pharmacokinetic parameters were obtained: AUC((0-96) (h)), AUC((0-∞)), C(max), C(max)/AUC((0-96) (h)), T(max), ke, and t(1/2). Results: Pharmacokinetic parameters presented normal distribution according to Probit's plot and Kolmogorov Smirnov's test, and the variance of AUC((0-96) (h)), AUC((0-∞)) or C(max) were homoscedastic. Geometric mean Tolrest/Zoloft individual percent ratio was 95.22% for AUC((0-96) (h)), 99.87% for C(max), 100.4% for AUC((0-∞)), 103.6% for Ke, 96.0% for t(1/2) and 93.7% for T(max). Conclusion: Since the 90% CI for both C(max) and AUC((0-96) (h)) mean ratio were within the 80-125% interval proposed by the Food and Drug Administration, it was concluded that Tolrest was bioequivalent to Zolof for both extent and rate of absorption in a single dose administration.
|Titolo:||Comparative bioavailability of two sertraline tablet formulations in healthy human volunteers after a single dose administration.|
|Data di pubblicazione:||1998|
|Appare nelle tipologie:||1.1 Articolo in rivista|