THE RELATIVE BIOAVAILABILITY OF TWO MARKETED CONTROLLED RELEASE DILTIAZEM DOSAGE FORMS AT STEADY STATE IN HEALTHY VOLUNTEERS
✍ Scribed by C. L. Lippert; T. Arumugham; V. O. Bhargava; M. Eller; S. J. Weir
- Publisher
- John Wiley and Sons
- Year
- 1996
- Tongue
- English
- Weight
- 472 KB
- Volume
- 17
- Category
- Article
- ISSN
- 0142-2782
No coin nor oath required. For personal study only.
✦ Synopsis
This study was conducted to determine the relative bioavailability of Dilacorm XR capsules compared to CardizemD CD capsules at both low (180mgdPL) and high (540mgd-') dose levels. Trough and serial plasma samples were obtained and pharmacokinetic parameters were calculated from the steady state concentration-time profiles. Mean steady state plasma diltiazem concentrations (AUC,,(&24)) of Dilacor XR were 19% and 26% lower than those of Cardizem CD for the 180mgd-L and 540mgd-I dose levels, respectively. In addition, Dilacor XR had lower mean C,,,,,,T,,,,,,C,,,,, and trough values than Cardizem CD with percentage differences ranging from 17% to 29%. The variability (%CV) in the data from the Dilacor XR treatments was higher for each calculated pharmacokinetic parameter compared to the Cardizem CD treatments. The %CV for Dilacor XR ranged from 34% to 104% while the %CV for Cardizem CD ranged from 21% to 49%. From these results, it may be concluded that Dilacor XR is not bioequivalent to Cardizem CD at steady state doses of 180mgd-' and 540mgd-I.