title: Assessments of pharmacokinetic drug interactions and tolerability of albendazole, praziquantel and ivermectin combinations.
abstract: 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.
authors.affiliation: Pharmacology and Toxicology Unit, Faculty of Allied Health Sciences, 99 Mu 18 Thammasat University (Rangsit Campus), Klong Loung, Pathumthani 12121, Thailand. kesaratmu@yahoo.com
authors.forename: K
authors.initials: K
authors.lastname: Na-Bangchang
authors.forename: S
authors.initials: S
authors.lastname: Kietinun
authors.forename: K K
authors.initials: KK
authors.lastname: Pawa
authors.forename: W
authors.initials: W
authors.lastname: Hanpitakpong
authors.forename: C
authors.initials: C
authors.lastname: Na-Bangchang
authors.forename: J
authors.initials: J
authors.lastname: Lazdins
mesh_terms: D000328:Adult; D015766:Albendazole / Q000031:analogs & derivatives / Q000097:blood / Q000493:pharmacokinetics; D000871:Anthelmintics / Q000097:blood / Q000493:pharmacokinetics; D000977:Antiparasitic Agents / Q000097:blood / Q000493:pharmacokinetics*; D018592:Cross-Over Studies; D004347:Drug Interactions; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007559:Ivermectin / Q000097:blood / Q000493:pharmacokinetics; D008297:Male; D011223:Praziquantel / Q000097:blood / Q000493:pharmacokinetics
chemical_list: D000871:Anthelmintics; D000977:Antiparasitic Agents; D011223:Praziquantel; D007559:Ivermectin; D015766:Albendazole; C027186:albendazole sulfoxide