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Bioequivalence Study of Two 50 mg Desvenlafaxine Extended Release Formulations: A Randomized, Single-Dose, Open-Label, Two Periods, Crossover Study

Acceso Abierto
ID Minciencias: ART-0000715565-5
Ranking: ART-ART_B

Abstract:

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 Tecnoquimicas 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 the Test and Reference products were 215.8 ng/mL and 196.9 ng/mL and for the area under the curve up to 48 hours (AUC0-t) 3849,6 ng.h/mL and 3605,4 ng.h/mL respectively. The 90% confidence interval for the Cmax parameter is within the range of 103,58-113,63 and for the AUC0-t parameter, the 90% confidence interval is within 97,96-111,39. Based on the FDA, EMA and WHO bioequivalence investigation guidelines, the CI is within the allowed ranges for bioequivalence and interchangeability declaration of the Tecnoquimicas S.A. product with the Reference product.

Tópico:

Analytical Methods in Pharmaceuticals

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Citations: 4
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Información de la Fuente:

SCImago Journal & Country Rank
FuenteJournal of Bioequivalence & Bioavailability
Cuartil año de publicaciónNo disponible
Volumen06
Issue04
PáginasNo disponible
pISSNNo disponible
ISSN0975-0851

Enlaces e Identificadores:

Scienti ID0000715565-5Minciencias IDART-0000715565-5Doi URLhttps://doi.org/10.4172/jbb.10000189
Open_access URLhttps://doi.org/10.4172/jbb.10000189Openalex URLhttps://openalex.org/W2131046611
Artículo de revista