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Table 2 Summary of Pharmacokinetic Parameters of Plasma Alpha1-PI Determined by Potency [Functional Activity] Assay

From: Pharmacokinetic comparability of Prolastin®-C to Prolastin® in alpha1-antitrypsin deficiency: a randomized study

 

Prolastin-C 60 mg/kg

Prolastin 60 mg/kg

Mean AUC0-7 days, mg*h/mL (% CV)

155.9 (17)

152.4 (16)

 

n = 23

n = 22

Mean Cmax, mg/mL (% CV)

1.797 (10)

1.848 (15)

 

n = 22

n = 23

Median adjusted tmax, hr (range)

0.673 (0.23-2.59)

0.820 (0.25-2.90)

 

n = 22

n = 23

Mean t½, hr (% CV)

146.3 (16)

139.3 (18)

 

n = 22

n = 22

  1. CV = coefficient of variation.