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Am. J. Trop. Med. Hyg., 76(6), 2007, pp. 1153-1157
Copyright © 2007 by The American Society of Tropical Medicine and Hygiene

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PHARMACOKINETICS OF AZITHROMYCIN AND THE COMBINATION OF IVERMECTIN AND ALBENDAZOLE WHEN ADMINISTERED ALONE AND CONCURRENTLY IN HEALTHY VOLUNTEERS

GUY W. AMSDEN*, THOMAS B. GREGORY, CHERYL A. MICHALAK, PAUL GLUE, AND CHARLES A. KNIRSCH
Clinical Research Division, Bassett Healthcare Research Institute, Bassett Healthcare, Cooperstown, New York; Clinical Research and Development, Pfizer Inc., New York, New York

Azithromycin is a critical component of an integrated disease elimination program against trachoma. This study was conducted to evaluate whether azithromycin has a pharmacokinetic interaction with the combination of ivermectin and albendazole. Eighteen healthy volunteers were administered single doses of azithromycin, ivermectin/albendazole, and the combination of the three agents in random, crossover fashion. To assess the presence of interactions, test (combination) and reference (single dose) data were compared using an estimation approach. Compared with reference phases, the geometric mean values for the combination arm’s azithromycin AUC0–t and Cmax were increased approximately 13% and 20%, respectively, albendazole AUC0–t decreased by approximately 3% and Cmax increased approximately 3%, and ivermectin AUC0–t and Cmax were increased 31% and 27%, respectively. Albendazole sulfoxide AUC0–t and Cmax were decreased approximately 16% and 14%, respectively. All treatments were well tolerated. The interactions for azithromycin and albendazole were minimal although the increase in ivermectin exposure requires further study.

Received April 24, 2006. Accepted for publication March 10, 2007.

Acknowledgments: We thank Drs. Grover Foster (Pfizer Inc.) and Janis Lazdins (Tropical Diseases Research Branch of the WHO) for their contributions to this effort. We also thank Jacob Kumaresan (International Trachoma Initiative) for his input. The American Society of Tropical Medicine and Hygiene (ASTMH) assisted with publication expenses.

Disclosure: Guy W. Amsden a consultant for Pliva d.d. and has done antimicrobial research for, Pfizer Inc., Abbott, Aventis, Bayer, GlaxoSmithKline, and Bristol-Myers Squibb. Paul Glue and Charles A. Knirsch work for Pfizer, Inc., the sponsor of this study.

* Address correspondence to Guy W. Amsden, Clinical Research Division Bassett Healthcare, 1 Atwell Road, Cooperstown, NY 13326. E-mail: guy.amsden{at}bassett.org

Authors’ addresses: Guy W. Amsden, Thomas B. Gregory, and Cheryl A. Michalak, Clinical Research Division, Bassett Healthcare, 1Atwell Road, Cooperstown, NY 13326, Telephone: 607-547-3399, Fax: 607-547-6914, E-mail: guy.amsden{at}bassett.org. Paul Glue and Charles A. Knirsch, Clinical Research and Development, Pfizer Inc. New York, NY 10017.

Reprint requests: Guy W. Amsden, Clinical Research Division, Bassett Healthcare, 1Atwell Road, Cooperstown, NY 13326.






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Copyright © 2007 by the American Society of Tropical Medicine and Hygiene.