| 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. | |
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MedLine Citation:
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PMID: 20332125 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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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Authors:
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Uwe Fuhr; Daniel Tuculanu; Alexander Berghout; Sigrid Balser; Arnd Schwebig; Paul Saenger |
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Publication Detail:
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Type: Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2010-03-23 |
Journal Detail:
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Title: European journal of endocrinology / European Federation of Endocrine Societies Volume: 162 ISSN: 1479-683X ISO Abbreviation: Eur. J. Endocrinol. Publication Date: 2010 Jun |
Date Detail:
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Created Date: 2010-05-21 Completed Date: 2010-06-28 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9423848 Medline TA: Eur J Endocrinol Country: England |
Other Details:
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Languages: eng Pagination: 1051-8 Citation Subset: IM |
Affiliation:
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Clinical Pharmacology Unit, Department of Pharmacology, Hospital of the University of Cologne, Cologne, Germany. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Administration, Oral Adult Area Under Curve Cross-Over Studies Double-Blind Method Female Human Growth Hormone / administration & dosage*, pharmacokinetics* Humans Male Pharmaceutical Solutions Recombinant Proteins / administration & dosage*, pharmacokinetics* Suspensions Therapeutic Equivalency |
| Chemical | |
Reg. No./Substance:
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0/Pharmaceutical Solutions; 0/Recombinant Proteins; 0/Suspensions; 12629-01-5/Human Growth Hormone |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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