Journal of Bioequivalence & Bioavailability

Abstract

An Open Label, Balanced, Randomized, Two Treatments, Two Sequences, Two Periods, Crossover, Single Dose, Bioequivalence Study of Olmesartan medoxomil/Hydrochlorothiazide 20 mg/12.5 mg Coated Tablets of Abbott and Olmetec plus® (Olmesartan medoxomil/Hydrochlorothiazide) 20 mg/12.5 mg Coated Tablets of Daiichi-Sankyo in Healthy, Adult, Human Subjects Under Fasting Condition

Arjun Arumugam O*, Geethalakshmi G, Srinivas G, Hurtado-Colorado Karen, Higuera Maria Juliana, Gavino-Gutiérrez Arquímedes M, Lara Claudia, Cereceda Gabriel, Leon Isaac, Tagle Arturo Ruiz, Gonzalez Camila, Pinto Deny, Echeverria Patricia, Lobos María Francisca, Calderon Sebastián, Sosa María del Milagro, Sasso Jaime, Kramm Karina and Jimenez Julio

Olmesartan Medoxomil and Hydrochlorothiazide is a combination of an Angiotensin II receptor antagonist (olmesartan medoxomil) Thiazide diuretic (Hydrochlorothiazide) used in the treatment of mild to moderate essential hypertension in patients who requires combination therapy. The purpose of this study was to evaluate the bioequivalence between Olmesartan Medoxomil/Hydrochlorothiazide 20 mg/12.5 mg coated tablets of Abbott and Olmetec Plus^® (Olmesarten Medoxomil/Hydrochlorothiazide) 20 mg/12.5 mg coated tablets of Daiichi-Sankyo in healthy, adult, human subjects. An open label, balanced, randomized two treatments, two sequences, two periods, crossover, single dose study with washout period of 02 days under fasting condition was carried out in 28 subjects in the age group of 20 to 44 years and 27 subjects completed the study. All the subjects included in the study were males and Asians. The pharmacokinetic samples collected from subjects who completed the study were analysed to determine the plasma concentration of Olmesartan and Hydrochlorothiazide using a validated bio-analytical method. Hydrochlorothiazide is the 90% confidence interval of the relative mean C_max, AUC_0-t and AUC_0-∞ of Hydrochlorothiazide were 94.40%-107.65%, 94.97%-105.83%, 95.00%-105.67% respectively, which were within the acceptable limits of 80.00 to 125.00%. Olmesartan: The 90% confidence interval of C_max, AUC_0-t and AUC_0-∞ for Olmesartan were 92.31%-107.60%, 91.81%-104.11% and 92.76%-104.56% respectively, which were within the acceptable limits of 80.00% to 125.00%.

Published Date: 2023-10-13; Received Date: 2023-09-11