Bioavailability of ambroxol sustained release preparations. Part II: Single and multiple oral dose studies in man
Janssen, T.J.; Guelen, P.J.; Vree, T.B.; Botterblom, M.H.; Valducci, R.
Arzneimittel-Forschung 38(1): 95-97
1988
ISSN/ISBN: 0004-4172 PMID: 3365282 Document Number: 354
The bioavailability of a new ambroxol sustained release preparation (75 mg) based on a dialyzing membrane for controlled release was studied in healthy volunteers after single and multiple oral dose in comparison with a standard sustained release formulation in a cross-over study under carefully controlled conditions. Plasma concentrations of ambroxol were measured by means of a HPLC method. Based on AUC data both preparations are found to be bioequivalent, but show different plasma concentration profiles. The test preparation showed a more pronounced sustained release profile than the reference preparation (single dose) resulting in significantly higher steady state plasma levels.
Document emailed within 1 workday
