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

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 Cmax, AUC0-t, AUC0-? and secondary parameters like Tmax, t1/2, Kel, 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 Cmax, AUC0-t and AUC0-?. 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.