ORAL SOLUTIONS OF SANG35 VERSUS NEORAL IN STABLE ADULT RENAL ALLOGRAFTS

$29,529M01FY2000RRNIH

University Of Alabama At Birmingham, Birmingham AL

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Abstract

This study examined the effect of converting stable renal transplant recipients from Neoral. brand of cyclosporine to SangCyA., a new bioequivalent preparation. The study was blinded, with a crossover design. Half of 45 subjects were randomized to receive SangCya for 2 weeks, then switched back to Neoral for the remainder of one year. The other half remained on Neoral for 2 weeks, then swithched to SangCya for the duration. Pharmacokinetic profiles were obtained prior to each change in cyclosporine preparation, and again at six months. The results of the study documented that patients on both preparations fared equally well clinically, and no difference was observed in trough cyclosporine blood levels or pharmacokinetic profiles between the two study groups. This study is now complete; a final IRB report has not yet been submitted.

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