Systemic pharmacokinetic (PK) study of buprenorphine (B) in mild to moderate chronic hepatic impairment (CHI)

K. C. Lasseter, J. Venitz, A. Eltahtawy, J. Miotto, C. Munera, R. Reder, B. E. Reidenberg

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7 Scopus citations

Abstract

Purpose: Evaluation of possible effects of CHI on the systemic PK of B. Methods: Open-label, parallel-group, single-dose clinical study comparing the PK of I.V. B (0.3 mg over 10 minutes) in subjects with CHI (n=8 Childs Pugh A, n=4 Childs Pugh B) and age, weight and sex matched healthy controls (n=12). Plasma concentrations of B and norbuprenorphine (nor-B) were measured using HPLC-MS/MS assays. Systemic exposure was assessed using AUCt, AUC, Cmax for B and AUCt, Cmax for nor-B. The 90% confidence intervals of log-transformed ratios were used to compare both groups. Safety evaluation included physical/lab results and AEs. Results: No difference in AUC, t1/2, Vdss or CLtot for B was observed. Nor-B was formed in both groups, but plasma concentrations were highly variable and much less than B; AUCt for nor-B was not different between groups. Cmax was lower in CHI subjects for both B (50%) and nor-B (30%). CHI subjects had less nausea/vomiting than healthy subjects. Conclusions: No dosage adjustment of B is required in patients with mild to moderate CHI.

Original languageEnglish
Pages (from-to)P2
JournalClinical Pharmacology and Therapeutics
Volume69
Issue number2
StatePublished - 2001

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