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Table 3 Pharmacokinetic (PK) parameters of recombinant human growth hormone (r-hGH) in serum (n = 28, PK population)

From: Comparison of the pharmacokinetics, safety and tolerability of two concentrations of a new liquid recombinant human growth hormone formulation versus the freeze-dried formulation

Parameter

Formulation

 

A

B

C

AUC0-t, ng/mL*h

295 (23.1)

191-474

279 (26.2)

120-381

281 (23.6)

165-411

Cmax, ng/mL

39.8 (28.0)

21.9-70.9

39.8 (31.6)

18.9-67.8

41.6 (31.1)

18.4-75.6

AUC0-∞, ng/mL*h

306 (23.3)

200-480

291 (24.2)

135-386

291 (23.3)

170-418

tmax, h

4.0

2.0-7.0

4.0

2.0-6.0

4.0

2.0-6.0

t1/2, h

2.19 (32.0)

1.24-5.38

2.22 (27.2)

1.42-4.11

2.05 (30.2)

1.18-3.85

Vz/f, L

41.2 (41.3)

18.3-117.9

44.0 (45.3)

24.2-132.5

40.7 (40.5)

19.8-90.6

CL/f, L/h

13.1 (23.3)

8.3-20.0

13.7 (24.2)

10.4-29.5

13.8 (23.3)

9.6-23.5

  1. Geomean (geo CV%) and range, for tmax median and range are given.
  2. AUC0-t, area under the serum concentration-time curve from time 0 to the last measurable concentration time point after drug administration; AUC0-∞, total area under the serum concentration-time curve extrapolated to infinity; Cmax, maximum serum concentration; CL/f, apparent clearance; CV, coefficient of variation; t1/2, terminal elimination half life; tmax, time to reach Cmax; Vz/f, apparent volume of distribution.
  3. A = r-hGH liquid multi-dose, 5.83 mg/mL.
  4. B = r-hGH liquid multi-dose, 8.0 mg/mL.
  5. C = r-hGH freeze-dried 8.8 mg, reconstituted in 1.51 mL.
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BMC Clinical Pharmacology

ISSN: 1472-6904