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Table 2 Pharmacokinetic parameters by treatment and dose level

From: A glycosylated recombinant human granulocyte colony stimulating factor produced in a novel protein production system (AVI-014) in healthy subjects: a first-in human, single dose, controlled study

Treatment

Dose

N

Cmax

AUC(0–72)

AUC(0-∞)

Clearance

Terminal elimination half life

Estimated Alpha half life

Volume of distribution

Volume of distribution

Tmax*

 

mcg/kg

 

pg/mL

hr*pg/mL

hr*pg/mL

mL/min

hr

hr

L

L/kg

hr

AVI-014

4

16

16,944 (5,804)

138,993 (48,262)

139,818 (48,332)

43 (18)

15.1 (3.6)

3.4 (0.5)

58 (33)

0.73 (0.37)

4.5

Filgrastim

4

8

22,595 (6,076)

175,323 (50,665)

176,145 (51,004)

32 (8)

14.7 (3.9)

2.8 (0.6)

42 (19)

0.54 (0.27)

5

AVI-014

8

8

31,460 (7,927)

312,569 (81,029)

313,525 (81,043)

35 (11)

11.0 (2.2)

3.7 (0.3)

35 (18)

0.45 (0.23)

5

Filgrastim

8

8

41,442 (9,986)

347,053 (70,749)

347,489 (70,698)

36 (10)

9.8 (2.3)

3.1 (0.5)

31 (15)

0.35 (0.14)

6

  1. All values are means with (SD), except in the case of Tmax.
  2. * = median