Romanian Society of Pharmaceutical Sciences
 

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ASSESSMENT OF RELATIVE BIOAVAILABILITY OF TWO INDAPAMIDE TABLET FORMULATIONS AFTER ADMINISTRATION OF SINGLE DOSES TO FASTED CAUCASIAN SUBJECTS IN 2-WAY CROSSOVER STUDY

MARIA CODREANU 1,2, DIANA IACOB 3, ANA-MARIA VLASE 4*, DANA MARIA MUNTEAN 1, LAURIAN VLASE 1

1Department of Pharmaceutical Technology and Biopharmacy, Faculty of Pharmacy, “Iuliu Haţieganu” University of Medicine and Pharmacy, Cluj-Napoca, Romania
2 Regulatory Affairs Department, Antibiotice SA, Iași, Romania
3 Centre for Drug Evaluation, Antibiotice SA, Iași, Romania
4 Department of Pharmaceutical Botany, Faculty of Pharmacy, “Iuliu Haţieganu” University of Medicine and Pharmacy, Cluj-Napoca, Romania

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This study aimed to evaluate the in vivo bioavailability of two formulations of indapamide 1.5 mg prolonged-release tablets, comparing the rate and extent of absorption. The bioequivalence was assessed on 22 healthy Caucasian subjects under fasted condition, with all the participants completing the crossover. The clinical trial was designed as an open label, blind, randomized, single-dose, two-treatment, two-period, two sequence, crossover study, with a wash-out period of 14 days. Blood sampling for determination of indapamide concentrations was performed before drug administration and post-dose at regular intervals in each treatment period up to 96 hours after drug administration. The individual plasma concentrations of indapamide were determined by a validated LC-MS/MS method. The pharmacokinetic parameters were calculated using the non-compartmental method and the logarithmically transformed data of Cmax and AUCs were analyzed using ANOVA. The 90% confidence intervals for the evaluated PK parameters were within the acceptance standard range for bioequivalence of 80.00 - 125.00%, therefore the investigated products are bioequivalent under fasted condition.