Vargas Jba
Colombia
Research Article
Bioequivalence Study of Two 50 mg Desvenlafaxine Extended Release
Formulations: A Randomized, Single-Dose, Open-Label, Two Periods,
Crossover Study
Author(s): Vargas M, Villarraga E and Vargas JbaVargas M, Villarraga E and Vargas Jba
This is a pharmacokinetic study of two formulations containing Desvenlafaxine succinate 50 mg extended release. Its objective was to compare the bioavailability between the Test product (Desvenlafaxine ER produced by Tecnoquímicas S.A., Colombia laboratory) and the Reference product (Pristiq XR® produced by Wyeth laboratory) and to be able to determine the Bioequivalence between the both of them. For this, an open label, two periods, two previously randomized sequences, crossover, single postprandial 100 mg dose study with an 8 days washout period between each period in 24 healthy volunteers was performed, including the collection of 13 plasma samples within 0 and 48 hours from all volunteers who participated in the clinical phase. The analytical method used was High Performance Liquid Chromatography (HPLC) with UV detector. The obtained mean peak concentration (Cmax) for t.. View More»
DOI:
10.4172/jbb.10000189