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

GUY W. AMSDEN Clinical Research Division, Bassett Healthcare Research Institute, Bassett Healthcare, Cooperstown, New York; Clinical Research and Development, Pfizer Inc., New York, New York

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THOMAS B. GREGORY Clinical Research Division, Bassett Healthcare Research Institute, Bassett Healthcare, Cooperstown, New York; Clinical Research and Development, Pfizer Inc., New York, New York

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CHERYL A. MICHALAK Clinical Research Division, Bassett Healthcare Research Institute, Bassett Healthcare, Cooperstown, New York; Clinical Research and Development, Pfizer Inc., New York, New York

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PAUL GLUE Clinical Research Division, Bassett Healthcare Research Institute, Bassett Healthcare, Cooperstown, New York; Clinical Research and Development, Pfizer Inc., New York, New York

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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

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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.

Author Notes

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