Effect of dihydro-artemisinin on the pharmacokinetics of gliclazide in diabetic subjects

Abstract

Diabetic patients do have co-occurring diseases like malaria, especially in tropical regions. Hence, polypharmacy is sometimes unavoidable. Gliclazide is widely used in the treatment of non-insulin-dependent type 2 diabetes mellitus, while dihydro-artemisinin (DHA) is one of the most promising medications used in the treatment of malaria on account of its good efficacy and tolerability. The study evaluated the effect of DHA on the pharmacokinetics of gliclazide in diabetic patients. This is a single dose one-way, cross-over study in two periods, with each phase preceded by an overnight fast. Six subjects that passed inclusion criteria participated in the study. The volunteers acted as their control. Phase 1 of the study involved administering a single oral dose of 80 mg of gliclazide after an overnight fast. After a washout period of one week, 80 mg gliclazide and 120 mg DHA were co-administered. Serial blood samples were collected at time intervals throughout 24 h and processed. A validated HPLC method was used to estimate serum gliclazide concentration, while the glucose oxidase peroxidase method was used in the evaluation of blood glucose concentration. The Pharmacokinetic Software - PharmPK was used to generate the pharmacokinetic parameters. GraphPad Prism version 7.01 software for window was used for data analysis. Statistical differences observed in the pharmacokinetic profiles of gliclazide and blood glucose concentration were not significant. Single oral dose of gliclazide and dihydro-artemisinin had good safety and tolerability in diabetic subjects.

Keywords: Diabetes mellitus, Dihydro-artemisinin, Drug Interactions, Gliclazide, Pharmacokinetics