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Dose Linearity of Glimepiride in Healthy Human Egyptian Volunteers

The present study was adopted to evaluate the pharmacokinetics and dose linearity of glimepiride after administration of single oral doses of 1–6 mg glimepiride in an open‐label, five‐way crossover study. Twenty‐four healthy male Egyptian volunteers were given 1, 2, 3, 4, and 6 mg of glimepiride on five occasions, and blood samples were collected over 24 hours. Plasma glimepiride concentrations were assayed by a validated reversed‐phase high‐performance liquid chromatography method with UV detection and the data were evaluated by non‐compartmental methods to determine pharmacokinetic parameters. The mean elimination half‐lives (t1/2) did not vary with the dose. The peak plasma levels (Cmax) and area under the plasma level versus time curve (AUC) data showed dose‐proportional response. The time to peak plasma concentration (tmax), mean residence time, oral clearance (Cl/F) and apparent volume of distribution (Vd/F) were all similar regardless of the administered dose (P > .05). The 90% confidence intervals of the ratios of dose‐adjusted log transformed values of Cmax, AUC0–t, AUC0–∞, t1/2, and tmax fell within the range of 80–125%. These findings suggest that glimepiride disposition is linear over the dose range studied healthy human Egyptian volunteers.