Ariyawansa J
Belgium
Research Article
Bioequivalence of Canagliflozin/Metformin Immediate Release Fixed-
Dose Combination Tablets Compared with Concomitant Administration of Single Components of Canagliflozin and Metformin in Healthy Fed Participants
Author(s): Devineni D, Curtin CR, Ariyawansa J, Weiner S, Stieltjes H, Vaccaro N, Shalayda K, Murphy J, DiProspero NA and Wajs EDevineni D, Curtin CR, Ariyawansa J, Weiner S, Stieltjes H, Vaccaro N, Shalayda K, Murphy J, DiProspero NA and Wajs E
Background: A fixed-dose combination (FDC) tablet formulation of canagliflozin, a selective inhibitor of sodium glucose co-transporter 2 (SGLT2), and metformin can potentially provide complimentary mechanism of action to improve glycemic control in adults with type 2 diabetes mellitus. Objectives: To assess the bioequivalence of immediate release (IR) FDC tablets containing canagliflozin and metformin relative to co-administration of individual tablets of IR canagliflozin and metformin in healthy fed participants. Methods: The six studies were randomized, open-label, single-center, single-dose, 2-treatment, 2-period crossovertrials conducted in healthy male and female participants under fed conditions. Pharmacokinetics of canagliflozin and metformin were investigated following administration of 2 canagliflozin/metformin IR FDC tablets (test) at 50 mg/500 mg, 50 mg/850 mg, 50 mg/1,000 .. View More»
DOI:
10.4172/jbb.1000199