PMID: 16625986Apr 22, 2006Paper

Plasma pharmacokinetics of desmopressin following sublingual administration: an exploratory dose-escalation study in healthy male volunteers

International Journal of Clinical Pharmacology and Therapeutics
I M SteinerChristian Joukhadar

Abstract

Desmopressin is usually administered intranasally in the treatment of central diabetes insipidus or nocturnal enuresis. The sublingual administration of desmopressin is expected to be an alternative to the intranasal route with advantages to children and to patients with allergic rhinitis or chronic rhinosinusitis. Therefore, the present study was carried out to explore the time-versus-concentration profile of desmopressin in plasma after sublingual administration to healthy volunteers. A total of 16 healthy male volunteers were enrolled in this open, exploratory, 1-period, randomized, dose-escalation study. Volunteers received a single sublingual dose of either 20, 40, 80, 160, 240 or 320 microg of desmopressin acetate. Desmopressin plasma concentrations were measured over a 12-hour period using a validated radioimmunoassay method. Safety and tolerability were assessed simultaneously. Plasma concentrations of desmopressin were below the lower limit of quantification (LLOQ) of 5 pg/ml for doses lower than 80 microg. For the doses of 160 - 320 microg the time-versus-concentration profiles were higher than the LLOQ. The area under the curve from 0 - 12 h (AUC0-12h) was 54.66 +/- 25.92 pg x h/ml after the 160 microg dose, 104.38 +...Continue Reading

Citations

Mar 20, 2009·Pharmaceutical Research·Nelly FransénErik Björk
Mar 20, 2010·Pharmaceutical Research·Keizo FukushimaKanji Takada
Sep 5, 2014·Journal of Clinical Pharmacology·Lei WuLakshmi Putcha
Mar 10, 2015·International Journal of Endocrinology and Metabolism·Kathleen De WaeleJean De Schepper
Dec 5, 2017·European Journal of Clinical Pharmacology·Robin MicheletUNKNOWN SAFE-PEDRUG consortium
Jun 9, 2020·Paediatric Drugs·Elke GasthuysJohan Vande Walle

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