title: The effects of an investigational antimalarial agent, NIPRD-AM1 on the single dose pharmacokinetics of metronidazole in healthy human volunteers.
abstract: The effect of concurrent administration of a novel phytomedicine, NIPRD-AM1 used for the treatment of malaria on the pharmacokinetics of metronidazole was investigated in healthy volunteers. The study was a completely randomized one, crossover involving administration of single dose metronidazole tablets (200 mg×2) concomitantly with NIPRD-AM1 capsules (250 mg×2) to 11 healthy volunteers. Blood samples were collected before and at pre-determined time intervals following administration of the drugs. Serum concentrations of the unchanged metronidazole were analyzed using a modified simple and sensitive reversed phase high performance liquid chromatography (HPLC) method. The method showed good precision for metronidazole with coefficient of variation less than 10%. The Pharmacokinetic parameters (AUC, Cmax, and Tmax) were generated using GraphPad Prism software version 2. The derived pharmacokinetic parameters (AUC, Cmax) following the administration of metronidazole alone and co-administration with NIPRD-AM1 were 76.12 μg/ml per hour, 7.94 μg/ml and 73.52 μg/ml per hour, 7.83 μg/ml, respectively. This differences were not statistically significant (P<0.05) and the relative bioavailability was found to be about 96%. The comparable relative bioavailabilty value obtained shows that there is little or no interaction between NIPRD-AM1 and metronidazole. The findings, therefore, showed that metronidazole can be administered with the phytomedicine NIPRD-AM1 without any significant effect on the pharmacokinetic profiles of metronidazole.
authors.affiliation: Department of Medicinal Chemistry and Quality Control, National Institute for Pharmaceutical Research & Development, Idu Industrial Area, P.M.B. 21, Abuja, Nigeria. obyobodozie@yahoo.com
authors.forename: Obiageri O
authors.initials: OO
authors.lastname: Obodozie
authors.forename: Benjamin U
authors.initials: BU
authors.lastname: Ebeshi
authors.forename: Kudirat B
authors.initials: KB
authors.lastname: Mustapha
authors.forename: Rukaiyatu A
authors.initials: RA
authors.lastname: Kirim
authors.forename: Margaret
authors.initials: M
authors.lastname: Ekpenyong
authors.forename: Uford S
authors.initials: US
authors.lastname: Inyang
mesh_terms: D000328:Adult; D000890:Anti-Infective Agents / Q000493:pharmacokinetics*; D000962:Antimalarials / Q000494:pharmacology*; D019540:Area Under Curve; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D004347:Drug Interactions; D005260:Female; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000493:pharmacokinetics*; D008875:Middle Aged; D010936:Plant Extracts / Q000494:pharmacology*; D055815:Young Adult
chemical_list: D000890:Anti-Infective Agents; D000962:Antimalarials; C557335:NIPRD-AM1; D010936:Plant Extracts; D008795:Metronidazole