Comparison of the pharmacokinetics,safety and tolerability of two concentrations of a new liquid recombinant human growth hormone formulation versus the freeze-dried formulation |
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| Authors: | Bernd Liedert Ulf Forssmann Peter Wolna Michaela Golob Andreas Kovar |
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| Affiliation: | (1) Merck KGaA, Darmstadt, Germany;(2) Merck Serono S.A., Geneva, Switzerland;(3) Merck KGaA, Grafing, Germany |
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| Abstract: | Background Somatropin is recombinant human growth hormone (GH) used for the treatment of growth failure in children and GH deficiency in adults. Two concentrations of a liquid formulation have been developed: 5.83 and 8.0 mg/mL. This trial compared the pharmacokinetics (PK), safety and tolerability of these two liquid concentrations against the freeze-dried (FD) formulation in healthy volunteers. |
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