| dc.creator | SAAVEDRA S.,IVÁN | |
| dc.creator | GAETE G.,LEONARDO | |
| dc.creator | CARRILLO C.,MITZY | |
| dc.creator | ORTIZ O.,MARIO | |
| dc.creator | ÁVILA C.,LUIS | |
| dc.creator | LEYTON M,SANTIAGO | |
| dc.creator | ROJAS G.,LILA | |
| dc.creator | GALLARDO M,NICOLÁS | |
| dc.creator | MUÑOZ B.,FERNANDO | |
| dc.creator | SALDAÑA V.,ADIELA | |
| dc.date | 2003-03-01 | |
| dc.date.accessioned | 2020-02-17T15:29:21Z | |
| dc.date.available | 2020-02-17T15:29:21Z | |
| dc.identifier | https://scielo.conicyt.cl/scielo.php?script=sci_arttext&pid=S0717-73482003000100004 | |
| dc.identifier.uri | https://revistaschilenas.uchile.cl/handle/2250/128462 | |
| dc.description | Objectives: To assess the relative bioavailability of two oral formulations of ambroxol commercialized in Chile, a generic syrup and the original product, MucosolvanR 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 (Cmax), area under the curve calculated from time zero to a determined time (AUC0-t), and area under the curve calculated from time zero to infinity (AUC0-oo), or in other parameters like: time to reach Cmax (t max), rate of absorption (Ka), rate of elimination (Ke), elimination half life (t1/2), and clearance (Cl). Conclusion: Pharmacokinetic results concluded that both formulations of ambroxol are bioequivalent and consequently the preparations can be considered interchangeable between them. | |
| dc.format | text/html | |
| dc.language | es | |
| dc.publisher | Sociedad Chilena de Enfermedades Respiratorias | |
| dc.relation | 10.4067/S0717-73482003000100004 | |
| dc.rights | info:eu-repo/semantics/openAccess | |
| dc.source | Revista chilena de enfermedades respiratorias v.19 n.1 2003 | |
| dc.subject | Bioavailability | |
| dc.subject | Bioequivalence | |
| dc.subject | Ambroxol syrup | |
| dc.title | Bioequivalencia de una formulación nacional de Ambroxol | |
