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The pharmacokinetic interactions and tolerability of albendazole, praziquantel and ivermectin combinations were assessed in 23 healthy Thai volunteers (12 males and 11 females). The study was an open, randomised, three-way crossover design in which each subject attended the study on three separate occasions (Phases I, II and III), of 4 d or 8 d each, with at least 1 or 2 weeks (but not longer than 2 months) between each phase. All subjects received the three study drug regimens as follows: regimen I, oral praziquantel (40 mg/kg body weight); regimen II, oral ivermectin (200 microg/kg body weight) given concurrently with an oral dose of albendazole (400 mg); and regimen III, oral ivermectin given concurrently with albendazole and praziquantel. All treatment regimens showed acceptable tolerability profiles. The incidence of overall drug-related adverse events was significantly higher following regimens I (12/23) and III (7/23) compared with that following regimen II (0/23). Six statistically significant changes in the pharmacokinetic parameters of albendazole sulphoxide (Cmax, AUC0-infinity, Vz/F, CL/F), praziquantel (Vz/F) and ivermectin (AUC0-infinity) were observed when the three drugs were given concurrently. However, based on US Food and Drug Administration criteria, these changes were not considered of clinical relevance.

Original publication

DOI

10.1016/j.trstmh.2005.05.017

Type

Journal article

Journal

Transactions of the Royal Society of Tropical Medicine and Hygiene

Publication Date

04/2006

Volume

100

Pages

335 - 345

Addresses

Pharmacology and Toxicology Unit, Faculty of Allied Health Sciences, 99 Mu 18 Thammasat University (Rangsit Campus), Klong Loung, Pathumthani 12121, Thailand. kesaratmu@yahoo.com

Keywords

Humans, Albendazole, Ivermectin, Praziquantel, Antiparasitic Agents, Anthelmintics, Drug Therapy, Combination, Cross-Over Studies, Drug Interactions, Adult, Female, Male