The study aims at investigating the effect of amodiaquine on the pharmacokinetic profile of gliclazide. It is a one-way single dose cross-over study in two phases. Six freshly diagnosed diabetic volunteers were used. The subjects acted as their own control, and each phase was preceded by an overnight fast. 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 300 mg amodiaquine were co-administered. Serial blood samples were collected over a period of 24 h during each phase into an Ethylenediaminetetraacetic acid (EDTA) vacutainer. After collection, blood samples were processed. A validated High Performance Liquid Chromatography (HPLC) method was used in the estimation of serum gliclazide concentration. Glucose oxidase peroxidase method was used in the estimation of blood glucose concentration. The pharmacokinetic parameters derived by a non-compartmental analysis with two periods (gliclazide alone and in combination with amodiaquine) were compared. The pharmacodynamics as measured by blood glucose concentration was also compared for the 2 phases of the study. Results showed that though amodiaquine affects the rate of absorption of gliclazide, it does not affect the bioavailability and overall disposition of gliclazide after a single oral dose. A lack of pharmacodynamic interactions between amodiaquine and gliclazide was also observed. Conclusively, amodiaquine and gliclazide can be concurrently administered together without fear of loss of activity.
Key words: Diabetes mellitus, gliclazide, amodiaquine, drug Interactions, pharmacokinetics.
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