A single-dose, open-label, two-treatment, two-period, two-sequence, two-way cross-over bioavailability & bioequivalence study to compare two formulation of Olmesartan 40 mg in healthy adults in fed state

Authors : Mohit Changani, Ameet Soni, Ambrish Singh, Harsh Choksi, Lokesh Kumar

DOI : 10.18231/j.ijpp.2019.026

Volume : 6

Issue : 4

Year : 2019

Page No : 121-125

Introduction: Olmesartan medoxomil is an ester prodrug commonly prescribed to treat high blood pressure, heart failure, and diabetic kidney disease.
Aim: To study the bioequivalence of Olvas tablets (containing olmesartan medoxomil 40mg) of Cadila Pharmaceuticals Ltd., India with Benicar® tablets (containing olmesartan medoxomil 40mg) of Daiichi Sankyo, Inc., Parsippany, New Jersey.
Materials and Methods: Forty healthy, adult, male subjects were studied in a single-dose, open-label, two-treatment, two-period, two-sequence, two-way cross-over study. Detailed demographic data along with clinical examination, vital signs, medical history, laboratory tests including hematology, biochemistry, serology and urine analysis. ECG and chest X-ray were performed. Pharmacokinetic primary parameters like C_max, AUC_0-t, AUC_0-? and secondary parameters like T_max, t_1/2, K_el, and AUC _{Extrapolation} were calculated for both the drug formulations.
Results: Demographic parameters were comparable for both the treatment arms. Olmesartan medoxomil 40mg of Cadila Pharmaceuticals Ltd was found to in the acceptance range for bioequivalence, 80.00-125.00% for the 90% confidence intervals for the difference of means of Ln-transformed parameters C_max, AUC_0-t and AUC_0-?.
Conclusion: Both Olmesartan Medoxomil tablets 40mg (containing olmesartan medoxomil 40mg) of Cadila Pharmaceuticals Ltd., India with Benicar® tablets 40mg (containing olmesartan medoxomil 40mg) of Daiichi Sankyo, Inc., Parsippany, New Jersey were found to be bioequivalent.

Keywords: Olmesartan, Bioavailability, Bioequivalence, Pharmacokinetics.

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