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. email@example.comShow MeSH
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Mentions: Seventy-one patients were recruited to the study and comprised the safety and intent-to-treat (ITT) populations. Three patients were excluded from the pharmacokinetic analysis due to protocol deviations: one patient was dispensed only 45 tablets instead of the planned 70, and substituted his own medication when he ran out of study medication; one did not have assessments performed according to protocol; and one was not on a stable twice-daily dose of study drug prior to entry. The pharmacokinetic population thus comprised 68 patients. A total of 65 patients (91.5%) completed the study (Figure 2). Six patients discontinued the study (four in sequence 1 and two in sequence 2), with one patient discontinuing due to adverse events, two due to consent withdrawal and three for protocol deviations. Two of the discontinuing patients were also protocol violators; results from the other four discontinuing patients were included in individual analyses if the relevant data had been recorded prior to study withdrawal.
Affiliation: Division of Nephrology, Section of Transplantation, University of Cincinnati, Cincinnati, OH, USA. firstname.lastname@example.org