This trial is a randomized, single dose, crossover study that will evaluate the acute safety, tolerability, pharmacokinetics and anti-platelet equivalence of aspirin compared with PL 2100 Aspirin-PC at 325mg and 650mg dose levels in approximately 32 healthy volunteers. This trial is a first step in a clinical development program that will investigate PL 2100 Aspirin-PC as an aspirin formulation that is potentially safer for the gastrointestinal (GI) tract.
There are two active investigational new drug applications for PL 2100, for prescription and non-prescription uses, with this trial designed to address the regulatory requirements of both. PL 2100 Aspirin-PC is novel formulation of aspirin that combines aspirin with a new gastro-protective agent, phosphatidylcholine.
Lenard Lichtenberger, co-founder of PLx Pharma, said: “PL 2100 Aspirin-PC may represent an alternative treatment for the large numbers of patients at risk for GI complications from aspirin use alone or when using aspirin with other drugs.”