A randomized pharmacokinetic study of generic tacrolimus versus reference tacrolimus in kidney transplant recipients.
Bottom Line: The ratios of geometric means were 1.02 (90% CI 97-108%, p = 0.486) for AUC(0-12h) and 1.09 (90% CI 101-118%, p = 0.057) for C(max) .Mean (SD) C(0) was 7.3(1.8) ng/mL for generic tacrolimus versus 7.0(2.1) ng/mL for reference tacrolimus based on data from days 14 and 28.Correlations between 12 h trough levels and AUC were r = 0.917 for generic tacrolimus and r = 0.887 for reference drug at day 28.
Affiliation: Division of Nephrology, Section of Transplantation, University of Cincinnati, Cincinnati, OH, USA. firstname.lastname@example.orgShow MeSH
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Mentions: This was an open-label, prospective, multicenter, randomized, two-period, two-sequence crossover, steady-state pharmacokinetic study conducted during October 2010–May 2011 (Figure 1). During a 14-day screening period, eligible patients continued to receive their current tacrolimus formulation at an unchanged dose. Following reevaluation for inclusion/exclusion criteria, patients were then randomized to remain on their current tacrolimus preparation or to switch to the alternative formulation on a milligram for milligram basis. During period 1 (days 1–14), patients in sequence 1 received reference tacrolimus (Prograf®, Astellas Pharma Inc., Deerfield, IL, USA) and patients in sequence 2 received generic tacrolimus. During period 2 (days 15–28), the two groups crossed over to receive the alternative preparation. The generic formulation was Sandoz tacrolimus (Sandoz Inc., Princeton, NJ, USA). Patients were instructed to take their study medication twice daily at 12 h intervals, at the same time each day. No food was allowed until 2 h post-dose.
Affiliation: Division of Nephrology, Section of Transplantation, University of Cincinnati, Cincinnati, OH, USA. email@example.com