Comparative bioavailability of a novel fixed-dose combination of ticagrelor and acetylsalicylic acid.

Dual antiplatelet therapy (DAPT) with acetylsalicylic acid (hereafter referred to as ASA) and ticagrelor is the standard of care for secondary prevention for atherothrombotic events, particularly in patients with noncardioembolic cerebrovascular disease or coronary artery disease. However, prolonged DAPT requires multiple daily tablets, which can compromise adherence; a fixed-dose combination could reduce pill burden and improve treatment persistence. This study evaluated the comparative bioavailability of a fixed-dose combination (FDC) capsule of ticagrelor 90 mg/ASA 100 mg (test) versus the concomitant administration of ticagrelor 90 mg tablet plus ASA 100 mg tablet (reference) under fasting conditions in healthy Mexican volunteers. We applied a randomized, open-label, two-period crossover, single-dose design with a 7-day washout and quantified plasma concentrations by liquid chromatography-tandem mass spectrometry. Twenty-four subjects were enrolled. Geometric mean ratios (90% confidence intervals) for ticagrelor maximum plasma concentration and area under the plasma concentration-time curve from 0 to 48 h, were 111.5% (102.3-121.5), and 100.3% (93.4-107.7); for salicylic acid, 95.4% (90.1-100.9), and 101.5% (96.7-106.5). All 90% confidence intervals fell within the predefined 80-125% range, and both formulations were well tolerated. These findings support the FDC as an alternative that may simplify long-term DAPT for the secondary prevention of atherothrombotic events.