A DOSE DUMPING STUDY WITH A SUSTAINED-RELEASE FORMULATION OF BUNAZOSIN (E1015) IN HEALTHY-VOLUNTEERS

The pharmacokinetics of a single oral dose of sustained-release bunazo sin 6mg were compared under fasting and nonfasting conditions in 12 he althy volunteers. Following ingestion of a high fat (59g) meal, the ex tent of pstrointestinal absorption of bunazosin was significantly redu ced in comparison with that obtained in the fasting state (mean peak p lasma bunazosin concentration 5.6 +/- 2.1 vs 12.8 +/- 4.5 mug/L; mean area under the bunazosin concentration-time curve 85.1 +/- 34.1 vs 114 .9 +/- 41.6 mug/L . h), whereas the rate of bunazosin absorption was n ot significantly modified (mean time to peak plasma concentration 4.9 +/- 1.2 vs 5.8 +/- 1.9 hours).