Pharmacokinetics of Posaconazole Administered Orally or by Nasogastric Tube in Healthy Volunteers

Author:

Dodds Ashley ES, Varkey JB, Krishna G, Vickery D, Ma L, Yu X, Malavade D, Goodwin M, Perfect JR, Power E

Date: 4 June 2009

Abstract:

Use of a nasogastric tube is one means of administering antifungal therapy to critically ill patients unable to receive medication via the oral route. This was a phase 1, open-label, single-center, randomized, crossover study of posaconazole administered via nasogastric tube in healthy volunteers. Each subject received 2 single doses of posaconazole 400 mg, one administered orally and one administered by nasogastric tube, with a 7-day washout period between each dose. Posaconazole was administered 5-10 minutes after subjects received a nutritional supplement. Blood samples for pharmacokinetic analysis were obtained up to 120 hours post-dose. The analysis of variance (ANOVA) estimate of the study population suggests that posaconazole nasogastric tube administration least square mean values of Cmax, AUC(tf), and AUC(I) were 81%, 76%, and 77%, respectively, of the corresponding oral administration values. The reason for lower Cmax and AUC values when posaconazole is administered via the nasogastric tube route is not known. Oral and nasogastric tube administration of a single dose of posaconazole suspension 400 mg was safe and well tolerated in healthy adult subjects. The incidence and nature of treatment-emergent adverse events were similar with both administration routes, and no serious adverse events, clinically significant laboratory, or vital sign abnormalities were reported. Obtaining plasma posaconazole concentrations may be warranted when posaconazole is given to patients via a nasogastric tube to ensure adequate posaconazole exposure. Strategies that have been shown to enhance posaconazole exposure (such as splitting the dose and minimizing the use of proton pump inhibitors) may also be used.

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