Bioequivalence between novel ready-to-use liquid formulations of the recombinant
human GH Omnitrope and the original lyophilized formulations for reconstitution
of Omnitrope and Genotropin.
Author(s): Fuhr U, Tuculanu D, Berghout A, Balser S, Schwebig A, Saenger P.
Affiliation(s): Clinical Pharmacology Unit, Department of Pharmacology, Hospital of the
University of Cologne, Cologne, Germany.
Publication date & source: 2010, Eur J Endocrinol. , 162(6):1051-8
OBJECTIVE: Two strengths of a novel ready-to-use liquid preparation of the
recombinant human GH (rhGH) Omnitrope were developed to increase the convenience
for the patients.
DESIGN: Omnitrope 3.3 mg/ml solution or Omnitrope 6.7 mg/ml solution was compared
to Omnitrope 5 mg/ml powder and Genotropin 5 mg/ml powder in terms of
pharmacokinetics, pharmacodynamics, safety, and local tolerance after a single
s.c. dose of 5 mg.
METHODS: Two randomized, double-blind, single-dose, three-way crossover studies
were carried out in 36 young healthy volunteers each. Endogenous GH secretion was
suppressed with a 25-h continuous i.v. infusion of octreotide (40 microg/h)
starting 1 h before rhGH administration.
RESULTS: Pharmacokinetic parameters were similar for the three treatments in both
studies respectively. Bioequivalence criteria were met for area under the
concentration-time curve (AUC) and C(max). Likewise, the pharmacodynamic
parameters for IGF1, IGF-binding protein 3, and non-esterified fatty acid were
similar for all preparations. No differences in adverse events were observed
between groups.
CONCLUSIONS: Omnitrope 3.3 mg/ml solution, 6.7 mg/ml solution, and 5 mg/ml
powder, and Genotropin 5 mg/ml powder are bioequivalent, have similar
pharmacokinetic and pharmacodynamic profiles, and are equally safe. Overall, the
products can be considered to be therapeutically interchangeable.
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