Pharmacokinetic and Pharmacodynamic Assessment of a Novel, Pharmaceutical Lipid-Aspirin Complex

Summary

Prospective, Randomized, Crossover, Bioequivalence study

Timeline

Start

2008-02-11

Primary completion

2008-06-10

Completion

2008-06-10

Outcome

Met primary endpoint

paper PK parameters were similar for PL-ASA and IR-ASA, and met FDA-criteria for bioequivalence. PMID 31420787 ↗

paper PL-ASA's novel liquid formulation has similar PK and PD performance compared with IR-ASA, supporting functional and clinical equivalence. PMID 31420787 ↗

Publications

• Angiolillo DJ, Bhatt DL, Lanza F, Cryer B, Dong JF, Jeske W, Zimmerman RR, von Chong E, Prats J, Deliargyris EN, Marathi U. Pharmacokinetic/pharmacodynamic assessment of a novel, pharmaceutical lipid-aspirin complex: results of a randomized, crossover, bioequivalence study. J Thromb Thrombolysis. 2019 Nov;48(4):554-562. doi: 10.1007/s11239-019-01933-7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aspirin	Small molecule	325 mg	—
Subject	Aspirin	Small molecule	650 mg	—

Indications

No indication recorded.