SangCyA is a novel cyclosporine formulation that was compared with Neoral and Sandimmune (Novartis Pharmaceutical, E. Hanover, NJ) in various pilot and pivotal trials in healthy volunteers and in transplant patients to assess pharmacokinetic parameters, bioequivalence, and safety end points. Eleven studies compared SangCyA solution and Neoral (Novartis Pharmaceuticals, E. Hanover, NJ) or Sandimmune solutions using various designs. Study conditions in healthy volunteers included fasted and fed conditions, male and female gender, white and black race, TDx, Emit and HPLC assays, different Neoral manufacturing lots, and renal and hepatic transplant recipients. Multiple blood samples were obtained over 36 hours in healthy volunteers and 12 hours in transplant recipients and analyzed using different cyclosporine assays. Pharmacokinetic parameters were estimated using noncompartmental methods. SangCyA and Neoral were bioequivalent in healthy volunteer trials under fasted or fed conditions, in males and females, in whites and blacks, and using any of three assays (TDx, Emit, and HPLC). Bioequivalence and similar safety profiles of Sang-CyA and Neoral were also observed in renal and hepatic transplant recipients. Although Sandimmune and SangCyA were not bioequivalent in renal transplant, patients could be converted safely with a small dose decrease needed to maintain similar drug exposure. SangCyA and Neoral solutions are bioequivalent and interchangeable.
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