Bioavailability comparison between a Chilean generic preparation of ambroxol and the original product Bioequivalencia de una formulación nacional de ambroxol
Author
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Saavedra Saavedra, Iván
Author
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Gaete G., Leonardo
Author
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Carrillo, Mitzy
Author
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Ortíz, Mario
Author
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Ávila, Luis
Author
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Leyton, Santiago
Author
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Rojas, Lila
Author
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Gallardo, Nicolás
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Muñoz, Fernando
Author
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Saldaña, Adiela
Admission date
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2019-03-11T12:56:41Z
Available date
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2019-03-11T12:56:41Z
Publication date
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2003
Cita de ítem
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Revista Chilena de Enfermedades Respiratorias, Volumen 19, Issue 1, 2018, Pages 21-27
Identifier
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07175698
Identifier
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07177348
Identifier
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https://repositorio.uchile.cl/handle/2250/164635
Abstract
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Objectives: To assess the relative bioavailability of two oral formulations of ambroxol commercialized in Chile, a generic syrup and the original product, Mucosolvan R from Boehringer Ingelheim. Methods: A randomized, cross-over and double blind study was performed in twelve healthy volunteers who received a single oral dose of either Mucosolvan (90 mg) or the generic formulation with at least a 14 day washout period between each single dose. Multiple blood samples were collected after each dose, the plasma ambroxol concentrations were determined by a validated High Performance Liquid Chromatography assay. Results: The 95% confidence intervals for all parameters were within the accepted range of 80-125% for bioequivalence, suggested by the US FDA. Non statistically significant differences were found in the mean parameters of bioequivalence: mean peak concentration (C max), area under the curve calculated from time zero to a determined time (AUC 0-t), and area under the curve calculated
Bioavailability comparison between a Chilean generic preparation of ambroxol and the original product Bioequivalencia de una formulación nacional de ambroxol