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01-05-2020 | Correction

Correction to: Evaluation of the bioequivalence and food effect on the bioavailability of CC-486 (oral azacitidine) tablets in adult patients with cancer

Authors: Hani M. Babiker, Mohammed Milhem, Joseph Aisner, William Edenfield, Dale Shepard, Michael Savona, Swaminathan Iyer, Maen Abdelrahim, C. L. Beach, Barry Skikne, Eric Laille, Kao-Tai Tsai, Thai Ho

Published in: Cancer Chemotherapy and Pharmacology | Issue 5/2020

Excerpt

In the original publication of the article the author has found few incorrect values in the Table 1. The corrected Table 1 is given below.

Table 1

Food effect on the plasma pharmacokinetic parameters of the CC-486 300 mg Formulation B tablet

Condition	Statistic	AUCt (ng h/mL)	AUC_∞ (ng h/mL)	C_max (ng/mL)	T_max (h)	t_1/2 (h)	CL/F (L/h)	Vz/F (L)
Fasted	N	56	54	56	56	54	54	54
	Geometric Mean^a	224.9	234.5	131.7	NA	0.58	1280	1074
	Geometric %CV	68.4	62.9	70.4	NA	31.6	62.9	76.2
	Median	240	243	141	1.0	0.55	1230	1140
	Min, max	41.5, 1050	65.9, 1050	21.4, 608	0.50, 4.0	0.35, 1.7	286, 4550	228, 6310
Fed	N	55	44	55	55	46	44	44
	Geometric Mean^a	233.7	248.9	105.2	NA	0.78	1205	1279
	Geometric %CV	58.3	52.0	76.3	NA	55.2	52.0	80.5
	Median	250	250	116	2.0	0.68	1200	1160
	Min, Max	61.3, 554	78.9, 560	22.7, 337	0.50, 6.1	0.40, 6.2	536, 3800	399, 9350

PK parameter	Condition	N	Geometric mean^†	Ratio (%) of geometric means	90% CI of ratio (%) of geometric means	Intra-patient %CV
AUC_t (ng h/mL)	Fasted	56	227.8	101.7	(92.83, 111.5)	29.0
AUC_t (ng h/mL)	Fed	55	231.8	101.7	(92.83, 111.5)	29.0
AUC_∞ (ng h/mL)	Fasted	54	237.5	108.9	(98.48, 120.5)	28.3
AUC_∞ (ng h/mL)	Fed	44	258.7	108.9	(98.48, 120.5)	28.3
C_max (ng/mL)	Fasted	56	133.0	78.86	(68.58, 90.68)	45.5
C_max (ng/mL)	Fed	55	104.9	78.86	(68.58, 90.68)	45.5

PK parameter	Condition	N	Median	Median difference	90% CI of median difference (Fed–fasted)	P value
Tmax (h)^‡	Fasted	56	1.0	1.0	(0.75, 1.3)	< 0.001
Tmax (h)^‡	Fed	55	2.0	1.0	(0.75, 1.3)	< 0.001

N patients = the total number of patients for which the PK parameter could be calculated. AUC_∞, t_1/2, CL/F, and V/F could not be calculated in some instances, if there were not data from a sufficient number of time points after the occurrence of C_max

Slight differences in geometric means of AUC_∞ and C_max are due to different methods of calculation

AUC_t area under the plasma concentration–time curve from time 0 to time t, AUC_∞ area under the plasma concentration–time curve from time 0 extrapolated to infinity, C_max maximum plasma concentration, T_max time to C_max, t_1/2 terminal half-life, CL/F apparent total clearance, Vz/F volume of distribution, NA not applicable

^†Calculated using an analysis of variance (ANOVA) model

^‡Median and median difference (Test vs. Reference), and 90% CI of the median difference, are from Hodges-Lehmann estimate. The P value is from Wilcoxon signed-rank test

^aCalculated using summary statistics.

…

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