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Erschienen in:
25.03.2020 | Correction
Correction to: Evaluation of the bioequivalence and food effect on the bioavailability of CC-486 (oral azacitidine) tablets in adult patients with cancer
Erschienen in: Cancer Chemotherapy and Pharmacology | Ausgabe 5/2020
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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
|