Food-effect study on the pharmacokinetics of indapamide prolonged-release tablets

Abstract

Objective A comparative study was performed to evaluate the food impact on the pharmacokinetics of indapamide 1.5 mg prolonged release tablets (SR). Methods The data evaluated were collected from 2 randomized, single dose, 2-way crossover bioequivalence studies with administration of indapamide to healthy Caucasian volunteers under fasting and fed conditions, respectively. Forty-four eligible subjects aged 19–39 years were enrolled in both studies: 22 subjects received indapamide under fasting (study 1) and the other 22 under fed (study 2) conditions. Blood samples were collected following the same schedule before and up to 96.0 hours after drug administration. Blood concentration of indapamide were quantified by a validated LC-MS/MS method. A non-compartmental analysis was used to calculate the pharmacokinetic parameters. Mathematical deconvolution was applied to assess indapamide absorption. Statistical significance for differences in key pharmacokinetic parameters was evaluated using an ANOVA test, with a significance threshold of p < 0.05. Results In total, 44 subjects were included in analysis. The outcomes demonstrated that ingestion of food independently reduced the mean of tmax by 4.64 h and increased the value of Cmax by 19.7 ng/mL, while the AUC remained unchanged. Conclusions Notably, differences in drug absorption rate obtained after co-administration of indapamide with food had no significant influence in safety and efficacy of the drug.