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Titolo:
Pharmacokinetic-pharmacodynamic modeling of ipamorelin, a growth hormone releasing peptide, in human volunteers
Autore:
Gobburu, JVS; Agerso, H; Jusko, WJ; Ynddal, L;
Indirizzi:
SUNY Buffalo, Sch Pharm, Dept Pharmaceut, Buffalo, NY 14260 USA SUNY Buffalo Buffalo NY USA 14260 Dept Pharmaceut, Buffalo, NY 14260 USA Novo Nordisk AS, Dept Pharmacokineties, DK-2760 Maaloev, Denmark Novo Nordisk AS Maaloev Denmark DK-2760 neties, DK-2760 Maaloev, Denmark
Titolo Testata:
PHARMACEUTICAL RESEARCH
fascicolo: 9, volume: 16, anno: 1999,
pagine: 1412 - 1416
SICI:
0724-8741(199909)16:9<1412:PMOIAG>2.0.ZU;2-1
Fonte:
ISI
Lingua:
ENG
Soggetto:
GH RELEASE; MEN;
Keywords:
ipamorelin; growth hormone releasing peptide (GHRP); population pharmacokinetics/pharmacodynamics; indirect response model;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Life Sciences
Citazioni:
17
Recensione:
Indirizzi per estratti:
Indirizzo: Jusko, WJ SUNY Buffalo, Sch Pharm, Dept Pharmaceut, Buffalo, NY 14260 USA SUNY Buffalo Buffalo NY USA 14260 maceut, Buffalo, NY 14260 USA
Citazione:
J.V.S. Gobburu et al., "Pharmacokinetic-pharmacodynamic modeling of ipamorelin, a growth hormone releasing peptide, in human volunteers", PHARM RES, 16(9), 1999, pp. 1412-1416

Abstract

Purpose. To examine the pharmacokinetics (PK) and pharmacodynamics (PD) ofipamorelin, a growth hormone (GH) releasing peptide, in healthy volunteers. Methods. A trial was conducted with a dose escalation design comprising 5 different infusion rates (4.21, 14.02, 42.13, 84.27 and 140.45 nmol/kg over15 minutes) with eight healthy male subjects at each dose level. Concentrations of ipamorelin and growth hormone were measured. Results. The PK parameters showed dose-proportionality, with a short terminal half-life of 2 hours, a clearance of 0.078 L/h/kg and a volume of distribution at steady-state of 0.22 L/kg. The time course of GH stimulation by ipamorelin showed a single episode of GH release with a peak at 0.67 hours and an exponential decline to negligible GH concentration at all doses. Theipamorelin-GH concentration relationship was characterized using an indirect response model and population fitting. The model employed a zero-order GH release rate over a finite duration of time to describe the episodic release of GH. Ipamorelin induces the release of GH at all dose levels with theconcentration (SC50) required for half-maximal GH stimulation of 214 nmol/L and a maximal GH production rate of 694 mIU/L/h. The inter-individual variability of the PD parameters was larger than that of the PK parameters. Conclusions. The proposed PK/PD model provides a useful characterization of ipamorelin disposition and GH responses across a range of doses.

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Documento generato il 11/07/20 alle ore 11:23:24