TABLE 3.
Summary of PK parameters (PK set—part 2)
| CT‐P39 (N = 47) | EU‐omalizumab (N = 49) | US‐omalizumab (N = 50) | |
|---|---|---|---|
| AUC0–last (d·µg/ml), a mean (SD) | 846.0 (251.9) | 843.8 (248.0) | 850.0 (213.1) |
| AUC0–inf (d·µg/ml), a mean (SD) | 910.9 (278.6) b | 897.7 (270.3) | 926.3 (273.3) |
| C max (µg/ml), a mean (SD) | 20.08 (5.994) | 18.24 (4.998) | 19.43 (5.416) |
| T max (d), median (range) | 7.098 (2.00–14.26) | 7.306 (3.00–18.26) | 7.183 (3.00–21.17) |
| t 1/2 (d), mean (SD) | 29.30 (9.516) b | 27.69 (5.560) | 28.63 (6.629) |
| λ z (1/d), mean (SD) | 0.02543 (0.006227) b | 0.02619 (0.006173) | 0.02536 (0.005447) |
| CL/F (L/d), mean (SD) | 0.1820 (0.06204) b | 0.1850 (0.07120) | 0.1764 (0.05601) |
| V z /F (L), mean (SD) | 7.258 (1.912) b | 7.172 (2.176) | 7.011 (1.808) |
| %AUCext (%), mean (SD) | 5.513 (5.429) b | 5.669 (3.783) | 6.519 (9.642) |
Abbreviations: %AUCext, percentage of the AUC0–inf obtained by extrapolation; AUC0–inf, area under the concentration–time curve from time zero to infinity; AUC0–last, area under the concentration–time curve from time zero to the last measurable concentration; CL/F, apparent total body clearance; C max, maximum serum concentration; d, day; EU‐omalizumab, European Union‐approved reference omalizumab; PK, pharmacokinetic; SD, standard deviation; t 1/2, terminal half‐life; T max, time to maximum concentration; US‐omalizumab, United States‐licensed reference omalizumab; V z /F, apparent volume of distribution during terminal phase; λ z , terminal elimination rate constant.
Primary PK parameter.
Data were analysed for n = 46 participants.