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Central Research Division, Pfizer, Inc., New York, New York
The
1-adrenoceptor antagonists doxazosin and terazosin and the 5
-reductase inhibitor finasteride are used in the treatment of benign prostatic hyperplasia. The aim of this study was to assess the potential pharmacokinetic inteaction of doxazosin or terazosin when coadministered with finasteride. This was a randomized, placebo-cotrolled, multi-center study. Ninety healthy men were assigned to one of six treatment groups: doxazosin; doxazsin plus finasteride; terazosin; terazosin plus finasteride; placebo; and placebo plus finasteride. Plasma concentrations, maximum plasma concentration (Cmax), time to maximum concentration (tmax), and area under the plasma concentration-time curve from 0 to 24 hours (A UC0-24) of doxazosin, terazosin, and finasteride were determined. Ratios of Cinax and AUC for doxazosin and terazosin were not significantly altered by coadministration with finasteride. The Cmax and AUCO0-24 of finasteride were not significantly altered by coadministration with doxazosin. However, Cmax and AUC0-24 of finasteride were significantly higher after coadministration with terazosin. There is no statistically significant pharmacokinetic interaction between finasteride and doxazosin; however, there is a statistically significant interaction between finasteride and terazosin, which affects the pharmacokinetics of fiasteride but not those of terazosin. The clinical significance of this interaction remains to be determined.
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