This category A study was designed by Dr. Renlund, who then obtained support for the study from the SangStat Medical Corporation. Sang-35 is a new, generic formulation of cyclosporin that has previously been tested only in healthy volunteers and in a very small number of patients who have undergone renal transplant. The generic formulation appeared to be bioequivalent to Neoral. Dr. Renlund approached the SangStat Corporation with a protocol designed to test the efficacy of the new formulation in patients who have undergone cardiac transplantation. Dr. Renlund worked with the company and developed a mutually-agreeable protocol, which is now being carried out on the GCRC. The purpose of the study is to define the safety, tolerability, and pharmacokinetic equivalency of Sang-35 in """"""""healthy"""""""" heart transplant recipients. This is a two-component study. The first part is a double-blind, randomized, single-center (Utah), crossover pharmacokinetic evaluation. The second part is a parallel safety-tolerability study. An important cost saving might result if Sang-35 proved to be a bioequivalent formulation of cyclosporin. The drug has proven to be safe, and the efficacy portion of the study has not yet been completed. Preliminary results from the study will be presented at the American Society of Transplant Physicians to be held in May of 1999.
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