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. 2020 Mar 25;85(5):1009–1010. doi: 10.1007/s00280-020-04056-6

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

Hani M Babiker 1,, Mohammed Milhem 2, Joseph Aisner 3, William Edenfield 4, Dale Shepard 5, Michael Savona 6, Swaminathan Iyer 7, Maen Abdelrahim 8, C L Beach 9, Barry Skikne 9,10, Eric Laille 9, Kao-Tai Tsai 9, Thai Ho 11
PMCID: PMC7645457  PMID: 32215699

Correction to: Cancer Chemotherapy and Pharmacology (2020) 85:621–626 https://doi.org/10.1007/s00280-020-04037-9

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) Cmax (ng/mL) Tmax (h) t1/2 (h) CL/F (L/h) Vz/F (L)
Fasted N 56 54 56 56 54 54 54
Geometric Meana 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 Meana 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
AUCt (ng h/mL) Fasted 56 227.8 101.7 (92.83, 111.5) 29.0
Fed 55 231.8
AUC (ng h/mL) Fasted 54 237.5 108.9 (98.48, 120.5) 28.3
Fed 44 258.7
Cmax (ng/mL) Fasted 56 133.0 78.86 (68.58, 90.68) 45.5
Fed 55 104.9
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
Fed 55 2.0

N patients = the total number of patients for which the PK parameter could be calculated. AUC, t1/2, 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 Cmax

Slight differences in geometric means of AUC and Cmax are due to different methods of calculation

AUCt 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, Cmax maximum plasma concentration, Tmax time to Cmax, t1/2 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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