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- W2029403914 abstract "Background/Aims Recommended initial dose of fentanyl (FEN) in opioid-naive patients is 25μg/h with upward titration. The aim was to assess the pharmacokinetics (PK), safety and tolerability of a FEN patch given with naltrexone (NAL), an opioid receptor antagonist. Methods In a randomized crossover study, healthy male subjects (n=24) received a single 72h application of two formulations of FEN (100μg/h) given with oral NAL (100mg) in a clinical setting. Blood samples were collected and serum FEN was assayed using a LC/MS/MS method. Results Mean (CV%) for AUC and Cmax were 142.7ng·h/mL (25.0) and 2.35ng/mL (34.8), respectively. PK parameters of FEN were similar for the reference product with and without NAL. Even though a high dose of FEN was administered, oral NAL prevented the occurrence of opioid adverse events (AEs). Of the 281 AEs, 139 were drug-related with 100 specific to the patch application site. Most AEs were mild and none were severe. Conclusions Co-administration of oral NAL did not affect the PK of FEN and prevented the occurrence of opioid AEs. Results from this study confirm that a 100μg/h dose of FEN was well tolerated and safe when given with NAL in healthy males. Clinical Pharmacology & Therapeutics (2005) 77, P76–P76; doi: 10.1016/j.clpt.2004.12.181" @default.
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- W2029403914 date "2005-02-01" @default.
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- W2029403914 title "Pharmacokinetics, safety and tolerability of a novel 100 ?g/h transdermal fentanyl patch co-administered with 100 mg oral naltrexone in healthy males" @default.
- W2029403914 doi "https://doi.org/10.1016/j.clpt.2004.12.181" @default.
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