Comparative Pharmacokinetics of Metronidazole in Healthy Volunteers and in Patients Suffering from Amoebiasis

Disease condition is one of the major factors which can affect the dose of a drug. This study was designed to compare the pharmacokinetic parameters of metronidazole in healthy volunteers and in patients suffering from amoebiasis and to recommend any modification of dose if required. The healthy volunteers were considered as Group A and the patients as Group B. Subjects from both groups were treated with metronidazole 400mg tablet orally. Blood sample of 5ml was collected at 0, 0.25, 0.5, 1.0, 2.0, 3.0, 6.0, 12.0, 24.0 and 36.0 hours from each individual and patient. Plasma was separated by centrifugation and stored at -80oC until assayed. The drug concentration in plasma was measured by High Performance Liquid Chromatographic (HPLC) method. The pharmacokinetic parameters were calculated using plasma concentration-time data employing software APO pharmacological analysis MW/PHARM (Version 3.02). The bioavailability of metronidazole after oral administration was considered as 1. Pharmacokinetic data of metronidazole in patients and in healthy volunteers were compared using unpaired t test. The data were presented as mean, standard deviation, standard error. No significant difference in pharmacokinetic parameters of metronidazole in amoebiasis patients and in healthy volunteers was noted after oral administration. Thus, there is no need for dose adjustment of metronidazole dose in amoebiasis patients.