Bioequivalence between ready-to-use recombinant human growth hormone (rhGH) in liquid formulation and rhGH for reconstitution.
The bioequivalence of recombinant human growth hormone (rhGH) for reconstitution, at either 24 IU or 8 mg, and three strengths of liquid formulation of rhGH (5, 10 or 15 mg per 1.5 ml, hGH) was tested in two randomized, single-blind, four-period, crossover studies in healthy subjects. The study drugs were administered by subcutaneous injection at a dose of 2.5 mg rhGH/m(2)body surface area or as a fixed dose of 5 mg rhGH. Endogenous hGH release was suppressed by a continuous somatostatin infusion. The 90% confidence intervals for the estimated mean ratios of AUC(0-24 h)and C(max)(analysis of variance) between all products were within 80-125% in both studies. Also, no significant differences (P> 0.05; Wilcoxon signed rank test) were found between t(max)for the liquid formulations of rhGH. These data demonstrate that there is bioequivalence between rhGH for reconstitution and the liquid formulations of rhGH.
Novo Nordisk A/S, Copenhagen, Denmark. LVJ@novo.dk
L V
LV
Jacobsen
P
P
Rolan
M S
MS
Christensen
K M
KM
Knudsen
M H
MH
Rasmussen
D000328:Adult; D000704:Analysis of Variance; D001835:Body Weight; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D018592:Cross-Over Studies; D005260:Female; D019382:Human Growth Hormone / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics; D016037:Single-Blind Method; D013004:Somatostatin / Q000494:pharmacology; D013810:Therapeutic Equivalency; D013997:Time Factors
D011994:Recombinant Proteins; D019382:Human Growth Hormone; D013004:Somatostatin