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Published on: November 8, 2024

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

Susana Tera-Ponce1,2, Perla E Castañeda-Tera2, Elva J García-Real2

  • 1Department of Pharmacology, Faculty of Medicine, National Autonomous University of Mexico (UNAM), Mexico City, Mexico.

Clinical Pharmacology in Drug Development
|July 20, 2026
PubMed

Insights

A new fixed-dose combination (FDC) capsule of ticagrelor and aspirin (ASA) demonstrated comparable bioavailability to separate tablets. This simplifies dual antiplatelet therapy (DAPT) for preventing atherothrombotic events.

Area of Science:

  • Pharmacology and Therapeutics
  • Clinical Pharmacology
  • Cardiovascular Medicine

Background:

  • Dual antiplatelet therapy (DAPT) with aspirin (ASA) and ticagrelor is standard for secondary prevention of atherothrombotic events.
  • Prolonged DAPT adherence is challenged by multiple daily tablets.
  • A fixed-dose combination (FDC) may reduce pill burden and improve treatment persistence.

Purpose of the Study:

  • To evaluate the comparative bioavailability of a ticagrelor 90 mg/ASA 100 mg FDC capsule versus separate tablets.
  • To assess the safety and tolerability of the FDC formulation.

Main Methods:

  • Randomized, open-label, two-period crossover, single-dose study in healthy Mexican volunteers.
  • Comparison of FDC capsule (test) against concomitant ticagrelor 90 mg and ASA 100 mg tablets (reference) under fasting conditions.
  • Plasma concentrations quantified by liquid chromatography-tandem mass spectrometry over 48 hours with a 7-day washout period.

Main Results:

  • Geometric mean ratios for ticagrelor Cmax and AUC0-48h were 111.5% (102.3-121.5) and 100.3% (93.4-107.7), respectively.
  • Geometric mean ratios for salicylic acid Cmax and AUC0-48h were 95.4% (90.1-100.9) and 101.5% (96.7-106.5), respectively.
  • All 90% confidence intervals fell within the acceptable 80-125% range; both formulations were well tolerated.

Conclusions:

  • The fixed-dose combination (FDC) of ticagrelor and ASA demonstrated bioequivalence to the separate administration of the drugs.
  • The FDC capsule is a viable alternative for simplifying long-term dual antiplatelet therapy (DAPT).
  • This simplification may enhance treatment adherence and persistence in patients requiring secondary prevention of atherothrombotic events.

Keywords:
acetylsalicylic acidcomparative bioavailabilitydual antiplatelet therapyfixed‐dose combinationhealthy Mexican volunteerspharmacokineticsticagrelor

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