Bioequivalence Between rhGH for Reconstitution and Ready-to-Use rhGH in Two Liquid Formulations

Objective To evaluate the bioequivalence between recombinant human growth hormone (rhGH) for reconstitution, and two dosages of liquid formulation of rhGH [(15IU) 5mg or (30IU) 10 mg per 3ml]. Methods The study drugs were tested in a randomized, single-blind and three-period crossover studies in 24 healthy male subjects. The three drugs were administered by subcutaneous injection at a dose of 0.2 IU/kg body weight. A continuous somatostatin infusion was given in order to suppress the secretion of endogenous GH. The venous blood samples were drawn at different time points to test the serum concentration of GH. The pharmacokinetic parameters were analyzed by statistical methods. Results 90% confidence intervals (CI) of AUC(subscript 0-24h) among three products were all within 80%-125% interval (103.4%-116.5%, 105.7%-119.6% and 91.9%-103.7%, respectively), and the CIs of C(subscript max) among three products were all within 70%-143% interval (91.9%-114.0% 103.7%-127.2% and 81.6%-97.4%, respectively). There was no statisitical difference of t(subscript max) among all the three products. Conclusion These data demonstrate that there is bioequivalence between rhGH for reconstitution and two liquid formulations of rhGH.