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Bioequivalence Study of Two Formulations Containing Bosutinib 500 mg Tablets in Healthy Colombian Volunteers

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ID Minciencias: ART-0000715565-32
Ranking: ART-ART_B

Abstract:

This is a pharmacokinetic study of two formulations containing Irbesartan 300 mg. Its objective was to compare the Bioavailability between the Test product (Irbesartan produced by Tecnoquimicas S.A., Colombia laboratory) and the Reference product (Aprovel® produced by Sanofi Aventis laboratory) in order to be able to state the Bioequivalence between them. For this, an open label, two periods, two randomized sequences, crossover, single fasting 300 mg dose study was performed with an 8-day washout period between each period in 24 healthy volunteers and collection of 12 plasma samples between 0 and 48 hours. The analytical method used was HPLC. The 90% confidence interval for the Cmax parameter was between 83.0 – 113.9 with a 97.2 ratio; for the AUC0-t parameter the 90% CI it is between 92.1 -116.7 with a 103.7 ratio, and for the AUC0-∞ the 90% CI was found to be between 95.5 – 114.8 with a 104.7 ratio. According to the European and FDA guidelines, the confidence interval falls within the permissible ranges for Bioequivalence and Interchangeability declaration of the Tecnoquimicas S.A. product with the Sanofi Aventis Reference product, Aprovel®

Tópico:

Biosimilars and Bioanalytical Methods

Citaciones:

Citations: 1
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Información de la Fuente:

SCImago Journal & Country Rank
FuenteJournal of Bioequivalence & Bioavailability
Cuartil año de publicaciónNo disponible
Volumen09
Issue01
PáginasNo disponible
pISSNNo disponible
ISSN0975-0851

Enlaces e Identificadores:

Scienti ID0000715565-32Minciencias IDART-0000715565-32Openalex URLhttps://openalex.org/W2556620634
Open_access URLhttps://doi.org/10.4172/jbb.1000314Doi URLhttps://doi.org/10.4172/jbb.1000314
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