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

Table 2 Estimates with 95% confidence intervals for ratios of geometric means in pharmacokinetic (PK) parameters of recombinant human growth hormone (r-hGH) in serum (n = 28, PK population)

Statistic	Formulation	AUC_0-t, ng/mL*h	C_max, ng/mL	AUC_{0-t adj}, ng/mL*h	C_{max adj}, ng/mL
				Adjusted for actual dose
Least squares geometric mean	A	293.1	39.52	317.4	42.80
	B	277.7	39.57	309.5	44.09
	C	280.1	41.43	306.1	45.26
CV%		12.2	16.2	12.3	16.2
Ratio estimate (95% CI)	A/C	1.05 (0.98, 1.12)	0.95 (0.88, 1.04)	1.04 (0.97, 1.11)	0.95 (0.87, 1.03)
	B/C	0.99 (0.93, 1.06)	0.96 (0.88, 1.04)	1.01 (0.95, 1.08)	0.97 (0.89, 1.06)
Ratio estimate (95% CI) (corrected for active content)	A/C^a	0.98 (0.91, 1.04)	0.89 (0.82, 0.97)	0.97 (0.91, 1.03)	0.88 (0.81, 0.96)
	B/C^b	0.96 (0.90, 1.02)	0.93 (0.85, 1.01)	0.98 (0.92, 1.05)	0.94 (0.87, 1.03)

^aCorrection factor: 93.18/99.9; ^bCorrection factor: 93.18/96.25.
A = r-hGH liquid multi-dose, 5.83 mg/mL.
B = r-hGH liquid multi-dose, 8.0 mg/mL.
C = r-hGH freeze-dried 8.8 mg, reconstituted in 1.51 mL.
AUC_0-t, area under the serum concentration-time curve from time 0 to the last measurable concentration time point after drug administration; C_max, maximum serum concentration; CI, confidence interval;
CV, coefficient of variation.