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Bioequivalence of Genotropin and Somatonorm
Author(s) -
WILTON PATRICK,
WIDLUND LARS,
GUILBAUD OLIVIER
Publication year - 1987
Publication title -
acta pædiatrica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.772
H-Index - 115
eISSN - 1651-2227
pISSN - 0803-5253
DOI - 10.1111/j.1651-2227.1987.tb17141.x
Subject(s) - bioequivalence , medicine , cmax , bioavailability , crossover study , pharmacokinetics , pharmacology , liter , area under the curve , placebo , alternative medicine , pathology
. Wilton, P., Widlund, L. and Guilbaud O. (Medical Department, KabiVitrum Peptide Hormones AB, Departments of Pharmacology and of Statistics and Computer Services, Research and Development, KabiVitrum AB, Stockholm, Sweden). Bioequivalence of Genotropin and Somatonorm. Acta Paediatr Scand [Suppl] 337:118, 1987. The bioequivalence parameters, AUC, C max and T max were calculated from serum hGH concentration‐time curves after subcutaneous injections of Genotropin (recombinant somatropin) and Somatonorm (somatrem) in a two‐period crossover study in 11 healthy men aged 21–35 years. C max was 53.4 and 62.9 mIU/litre and T max was 5.3 and 4.0 hours for Genotropin and Somatonorm, respectively. Criteria for bioequivalence were fulfilled for AUC. The bioavailability of Genotropin given subcutaneously was determined from the data obtained in the study above, and after an intravenous injection of Genotropin in the same dose (0.1 IUkg body weight). The measured bioavailability of 71% could be an overestimate due to interference by endogenous hGH.