Biology Reference
In-Depth Information
Table 2. Single-dose pharmacokinetic parameters of subcutaneously (SC) administered rHuEPO in
healthy volunteers
Ref
SC Dose (U/kg)n
T
max
(hr)
t
1/2,z
(hr)
F (%)
[20]
50
13 (6)
25 (12)
36 (23)
6
[epoetin alfa]
[15]
150
6
[8-24]
ID
a
ID
[epoetin alfa]
300
6
[12-24]
ID
ID
[epoetin alfa]
15 (8)
19.39 (10.71)
31.9 (9.1)
100
9
[7]
[epoetin alfa]
100]
15 (7)
24.18 (11.16)
32.7 (8.2)
9
[epoetin beta]
11.0
b
22.58
b
38.5
b
[18]
100]
12
[epoetin beta]
[8.0-24.0]
[10.30-26.76]
[9.0-60.3]
[21]
9,12
10.8, 12.3
NA
2
c
50
[epoetin alfa]
22.2 (8.1)
68.2 (52.2)
NA
[4]
300
5
[epoetin alfa]
450
5
15.6 (5.8)
24.2 (3.2)
NA
[epoetin alfa]
600
5
27.6 (9.1)
29.3 (9.4)
NA
[epoetin alfa]
900
5
22 (13.0)
36 (13.5)
NA
[epoetin alfa]
1200
5
26.4 (7.8)
78.5 (95.4)
NA
[epoetin alfa]
1350
5
23 (9.0)
33.4 (2.4)
NA
[epoetin alfa]
1800
5
28.8 (7.8)
32.4 (8.4)
NA
[epoetin alfa]
2400
5
25.2 (6.2)
43.6 (25.9)
NA
[epoetin alfa]
[22]
30
13
25.2
3
NA
[epoetin beta]
[12-15]
[18.0-33.2]
3
11
20.5
NA
60
[epoetin beta]
[5-12]
[14.4-24.4]
100
3
13
18.5
NA
[epoetin beta]
[12-15]
[12.5-23.6]
[12]
d
150
24
15.4 (7.5)
19.7 (12.8)
NA
[epoetin alfa]
750
24
16.6 (4.8)
25.7 (14.9)
NA
[epoetin alfa]
Values given as mean (SD) [range] unless otherwise indicated. Bioavailability (F) given for cross-over
studies unless otherwise indicated. NA, not available. T
max
,time at which peak concentration
observed.
a
insufficient duration of sample collection to fully characterize profile.
b
median.
c
individual values
d
values reported are for the human serum albumin-containing formulation.
presented.
