University of Khartoum

Ketoconazole Pharmacokinetics In Sudanese Patients With Mycetoma

Ketoconazole Pharmacokinetics In Sudanese Patients With Mycetoma

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Title: Ketoconazole Pharmacokinetics In Sudanese Patients With Mycetoma
Author: Mutasim, Abdelbadie
Abstract: The Plasma concentration of ketoconazole was assessed by estimation of the pharmacokinetic parameters for tow regimen 400 mg and 800 mg in mycetoma patients. The study was carried out in the Mycetoma research center, Soba hospital, Faculty of Medicine at the University of Khartoum. Twelve patients adult were included in this study following fulfillment of the inclusion and exclusion criteria of the study. Open randomized design was performed. Blood samples were collected at specified hours after medication with ketoconazole (400 mg or 800 mg). Concentrations of ketoconazole were measured in Plasma by HPLC method. Noncompartmental pharmacokinetic analysis was performed on the Plasma concentration-time data. The pharmacokinetic parameters (Mean ± SD) of ketoconazole determined following administration of first and last dose 400 mg regimen were estimated as: T1/2 4.24 ± 1.87h and 8.60 h, Cmax9.08 ± 3.96µg/ml and 11.56 µg/ml, Tmax2.33 ± 0.52 and 6 h, AUC 62.34 ± 31.03 and 183.07 µg.h/ml, MRT 8.15 ± 1.58 and 14.65 h, CL/F 8.78 ± 6.85 and 1.09 L/h, Vd/F 42.70 ± 14.67 and 13.55 L. For first and last dose 800 mg regimen, the parameters were as follows: T1/24.00 ± 0.66 h and 6.83 ± 2.15 h, Cmax17.21 ± 7.35 and 18.44 ± 7.53 µg/ml, Tmax2.17 ± 0.41 and 2.00 ± 0.82 h, AUC∞121.56 ± 71.52 and 264.56 ± 136.96 µg.h/ml, MRT 7.86 ± 3.28 and 12.49 ± 5.29 h, CL/F 8.79 ± 5.57 and 3.18 ± 2.48 L/h, Vd/F 49.28 ± 27.11and 36.66 ± 40.14 L. The study concluded that the Plasma concentration of the tow regimens is highly comparable with that of the published studies. Our results support the concept of a change in pharmacokinetics with chronic dosing. High dose may lead to accumulation of ketoconazole in the body and might lead to toxicity
Description: 158page
URI: http://khartoumspace.uofk.edu/handle/123456789/8318
Date: 2015-04-06


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