AIM: To determine the pharmacokinetics, safety and performance of a novel matrix formulation of fentanyl. METHODS:Transdermal fentanyl was administered as the novel matrix and the Durogesic reservoir formulations (24 subjects, 100 microg h(-1)) in a randomized, fully replicate, four-way crossover study. Serum concentrations of fentanyl were assayed by LC/MS/MS. Pharmacokinetic parameters of fentanyl and performance (adherence and skin irritability) were evaluated. RESULTS: Test/reference ratio (90% confidence intervals) for AUC(0-t), AUC(inf) and C(max) were 105.5% (99.4, 112.0), 105.3% (99.3, 111.6) and 111.4% (100.4, 123.6), respectively. Adherence and skin irritability results of the two formulations were similar. CONCLUSION: The two formulations are expected to result in similar efficacy for the management of severe pain.
RCT Entities:
AIM: To determine the pharmacokinetics, safety and performance of a novel matrix formulation of fentanyl. METHODS: Transdermal fentanyl was administered as the novel matrix and the Durogesic reservoir formulations (24 subjects, 100 microg h(-1)) in a randomized, fully replicate, four-way crossover study. Serum concentrations of fentanyl were assayed by LC/MS/MS. Pharmacokinetic parameters of fentanyl and performance (adherence and skin irritability) were evaluated. RESULTS: Test/reference ratio (90% confidence intervals) for AUC(0-t), AUC(inf) and C(max) were 105.5% (99.4, 112.0), 105.3% (99.3, 111.6) and 111.4% (100.4, 123.6), respectively. Adherence and skin irritability results of the two formulations were similar. CONCLUSION: The two formulations are expected to result in similar efficacy for the management of severe pain.
Authors: Rainer Freynhagen; Hans Jürgen von Giesen; Peter Busche; Rainer Sabatowski; Christhoph Konrad; Stefan Grond Journal: J Pain Symptom Manage Date: 2005-09 Impact factor: 3.612
Authors: Astrid W Oosten; João A Abrantes; Siv Jönsson; Peter de Bruijn; Evelien J M Kuip; Amílcar Falcão; Carin C D van der Rijt; Ron H J Mathijssen Journal: Eur J Clin Pharmacol Date: 2016-01-14 Impact factor: 2.953