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Antimicrobial Agents and Chemotherapy, March 2004, p. 804-808, Vol. 48, No. 3
0066-4804/04/$08.00+0     DOI: 10.1128/AAC.48.3.804-808.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.

Pharmacokinetics of Posaconazole Coadministered with Antacid in Fasting or Nonfasting Healthy Men

Rachel Courtney,* Elaine Radwanski, Josephine Lim, and Mark Laughlin

Schering-Plough Research Institute, Kenilworth, New Jersey

Received 7 April 2003/ Returned for modification 6 September 2003/ Accepted 18 November 2003

Posaconazole is a potent broad-spectrum azole antifungal agent in clinical development for the treatment of invasive fungal infections. This study evaluated the potential for a pH-dependent pharmacokinetic interaction between posaconazole and an antacid (Mylanta), under fasting and nonfasting conditions. Twelve men completed this randomized, four-period crossover, single-dose study. Subjects received 200 mg of posaconazole following a 10-h fast, with 20 ml of Mylanta and a 10-h fast, with 20 ml of Mylanta and a high-fat breakfast, and with a high-fat breakfast alone. Antacid coadministration had no statistically significant effects on posaconazole bioavailability under fasting or nonfasting conditions. In the fasting state, antacid slightly increased the relative oral bioavailability of posaconazole by 15% (P = 0.296); in the nonfasting state, antacid decreased the relative bioavailability of posaconazole by 12% (P = 0.352). Food increased the relative oral bioavailability of posaconazole by 400% (P = 0.001). In conclusion, the effect of antacid on posaconazole exposure in the fasting or nonfasting state was small and is not considered clinically significant.

* Corresponding author. Mailing address: Schering-Plough Research Institute, K-15-4-4455, 2015 Galloping Hill Rd., Kenilworth, NJ 07033. Phone: (908) 740-3836. Fax: (908) 740-2169. E-mail: rachel.courtney{at}spcorp.com.

Antimicrobial Agents and Chemotherapy, March 2004, p. 804-808, Vol. 48, No. 3
0066-4804/04/$08.00+0     DOI: 10.1128/AAC.48.3.804-808.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.



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