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: The mean (SD) tacrolimus dose at baseline was 5.7 (4.2) mg/day (median 4.0 mg/day, range 0.5–20.0 mg/day). All patients received an unchanged dose throughout the study. All measured tacrolimus trough concentrations were above the lower limit of quantitation (approximately 0.10 ng/mL). Figure 3 shows time–concentration profiles based on mean values of pharmacokinetic data obtained on days 14 and 28. There were no significant differences in AUC0–12h, C0, Cmax or tmax between the generic and reference preparations based on mean values of data obtained on days 14 and 28 (Table 1). The ratios of geometric means (ANOVA) were 1.02 (90% CI of 97–108%, p = 0.486) for AUC0–12h, 1.09 (90% CI 101–118%, p = 0.057) for Cmax and 1.02 (90% CI of 95–109, p = 0.651) for C12.
Affiliation: Division of Nephrology, Section of Transplantation, University of Cincinnati, Cincinnati, OH, USA. firstname.lastname@example.org