Evaluating the effect of artesunate on the pharmacokinetics of gliclazide in diabetic subjects

Abstract

Therapeutic management of diabetic patients frequently involves polypharmacy which is likely to provoke drug-drug interactions (DDIs). This may require appropriate monitoring and most common clinically relevant DDIs that occur with antidiabetic medications often leads to variations in therapeutic response. Due to the wide use of artesunate combination in the treatment of malaria in diabetic patients, drug interactions with gliclazide is a possibility. This study was aimed at determining the effect of artesunate on the pharmacokinetics of gliclazide in diabetic subjects. Six freshly diagnosed diabetics subjects participated in the study. Written informed consent was sought and obtained from the volunteers. The study is a one-way single dose cross-over study in two phases. Phase 1 of the study involved the administration of a single oral dose of 80 mg of gliclazide after an overnight fast. After a wash out period of one week, 80 mg gliclazide and 100 mg artesunate were co-administered. Serial blood samples were collected over a period of 24 h during each phase into an EDTA vacutainer. High Performance Liquid Chromatography method was used in the estimation of plasma glucose concentration; while the glucose oxidase peroxidase method was used in the estimation of plasma glucose concentration. Results showed changes in the pharmacokinetic parameters and blood glucose concentration were not significant (p>0.05). This shows that artesunate does not alter the pharmacokinetics and of gliclazide in diabetic patients after single oral dose administration; and hence can be co-administered without dose modification.

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Keywords: Diabetes mellitus, gliclazide, artesunate, drug Interactions, pharmacokinetics