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PEDIATRICS

Pharmacokinetics of Desmopressin Administrated as an Oral Lyophilisate Dosage Form in Children With Primary Nocturnal Enuresis and Healthy Adults

Ole Østerberg, PhD, Radojka M. Savic, MS, Mats O. Karlsson, PhD, Ulrika S. H. Simonsson, PhD, Jens Peter Nørgaard, MD, DMSc, Johan Vande Walle, MD and Henrik Agersø, PhD

From Ferring Pharmaceuticals A/S, Kay Fiskers Plads 11 DK-2300 Copenhagen S, Denmark (Dr Østerberg, Dr Nørgaard, Dr Agersø); Department of Pharmaceutical Biosciences, Uppsala University, Sweden (Mr Savic, Dr Karlsson, Dr Simonsson); Department of Pediatric Nephrology, UZ Gent, Belgium (Dr Walle).

The population pharmacokinetics of desmopressin in children with nocturnal enuresis and in healthy adults were compared using a 1-compartment model with first-order absorption and first-order elimination. In addition, the model consisted of a number of transit compartments before absorption to describe a lag-time. The model gave an adequate description of adult as well as children data and provided a statistically significant better fit to data than a standard lag-time model. The main difference in the pharmacokinetics between children and adults was the absorption delay. The pharmacokinetic difference was minor and presumably of no clinical relevance.

Key Words: Desmopressin • pharmacokinetics • primary nocturnal enuresis • modeling • transit absorption model

Address for reprints: Ole Østerberg, Ferring Pharmaceuticals A/S, Kay Fiskers Plads 11 DK-2300 Copenhagen S, Denmark.




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