Abstract
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.
Highlights
Phase 1 of the study involved the administration of a single oral dose of 80 mg of gliclazide after an overnight fast
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
The drug has been used in artemisinin combinations (WHO, 2003, 2006) in the treatment of malaria resistant Plasmodium falciparum (Raobela et al, 2018)
Summary
Diabetes mellitus is a condition primarily defined by the level of hyperglycaemia, in which the body’s cells are. Gliclazide has the advantage of less likely to experienced secondary failure (Wang et al, 2017), owing to their well‐ established efficacy and safety profile It is a drug of choice for the treatment of type 2 diabetes mellitus in the elderly (Sola et al, 2015), children and adolescents (Onge et al, 2015), pregnancy and lactation (Kavitha et al, 2013); and those with both micro-vascular and macro-vascular complications (Campbell, 1991; Avogadro, 2012; Azimova et al, 2014). The drug has been used in artemisinin combinations (WHO, 2003, 2006) in the treatment of malaria resistant Plasmodium falciparum (Raobela et al, 2018) With such widespread usage of amodiaquine combinations in diabetes patients, drug interactions with gliclazide become a possibility. This study, is aimed at investigating the effect of amodiaquine on the pharmacokinetic profile of gliclazide in freshly diagnosed diabetic volunteers
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