Tchaikapharma High Quality Medicines Inc., Science Department, 1 G.M Dimitrov Blvd, 1172 Sofia Bulgaria, Bulgaria
Research Article
Bioequivalence study of a new fixed-dose combination tablet containing irbesartan and hydrochlorothiazide in healthy volunteers
Author(s): Katya Uzunova, Andrey Petrov, Emil Gatchev, Velichka Pavlova, Elena Filipova*, Cintia Jimenez, Krassimir Kalinov and Toni Vekov
Background and objective: The combination antihypertensive therapy has shown greater blood pressure lowering potential as well as better adherence to the treatment. Therefore, a new generic fixed-dose combination containing irbesartan and hydrochlorothiazide was developed and rate and extend of absorption were compared with reference formulation to prove its bioequivalence in healthy volunteers.
Methods: A single-centre, open-label, randomized, two-period, crossover, single dose study under fasting conditions, including at least 7-days washout period, was performed in 30 healthy male and female volunteers. Twenty blood samples were collected in each study period: prior to dosing (0:00) and up to 72:00 hours after dosing and plasma concentrations of irbesartan and hydrochlorothiazide were analysed using preliminary validated methods.
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