TABLE 3.

Comparison of intracellular tacrolimus (Tac) pharmacokinetic variables and their corresponding correlations after morning Tac dose (0–12 h) and after night Tac dose (12–24 h) of twice-daily Tac formulation.

Variables	Morning dose (0–12 h)	Night dose (12–24 h)	p
Ctrough (pg/milion cells)	32.13 [25.41–40.62]	28.49 [22.42–36.21]	0.018 a
Cmax (pg/million cells)	95.0 [72.0–125.3]	61.9 [47.6–80.5]	<0.001 a
Tmax (h)	1.64 [1.14–2.11]	1.92 [1.46–2.89]	0.475 b
AUC (pg·h/million cells)	601.4 [478.1–756.5]	477.3 [373.7–609.7]	<0.001 a
Ctrough/AUC	0.053 [0.048–0.059]	0.059 [0.055–0.065]	0.085 a
PTF (%)	125.8 [105.6–149.9]	66.1 [51.9–84.2]	<0.001 a
SFI (%)	223.1 [176.5–297.0]	81.9 [59.6–112.4]	<0.001 a
Caverage (pg/million cells)	50.12 [39.84–63.04]	39.78 [31.14–50,81]	<0.001 a
Correlations c	Morning dose (0–12 h)		Night dose (12–24 h)
	R	p	R	p
C0 vs AUC0–12 h	0.902 c	<0.001	—	—
C12 vs AUC0–12 h	0.899 c	<0.001	—	—
C12 vs AUC12–24 h	—	—	0.934 c	<0.001
C24 vs AUC12–24 h	—	—	0.940 c	<0.001
C0 vs Cmax 0–12 h	0.738 c	<0.001	—	—
C12 vs Cmax 12–24 h	—	—	0.844 c	<0.001

^aPaired t-test.

^bWilcoxon-test.

^cPearson’s correlation test.

Data is represented as geometric mean [95% CI] unless T_max, that is expressed as median [interquartile range]. C_trough, trough concentration corresponding at time 12 h for morning dose and at time 24 h for night dose; C_max, maximum peak Tac concentration; T_max, time to reach C_max; AUC, area under the concentration-time curve from each 12 h dose interval; PTF, peak-trough fluctuation index defined as [(C_max − C_trough)/C_average]; SFI, swing fluctuation index defined as [(C_max − C_trough)/C_trough]; C_average, average Tac concentration from each 12 h dose interval; C₀, morning pre-dose concentration at time 0 h; C₁₂, night pre-dose concentration at time 12 h; C₂₄, Tac concentration at time 24 h; AUC_0–12 h, area under the concentration-time curve after the morning dose from 0 to 12 h; AUC_12–24 h, area under the concentration-time curve after the night dose from 12 to 24 h.