HOUSTON--(BUSINESS WIRE)--PLx Pharma Inc. announced today that is has initiated a Phase 1 clinical trial of PL 2100, also known as Aspirin-PC, its oral drug candidate for equivalent label claims for aspirin under a 505(b)(2) regulatory path. There are two active Investigational New Drug (IND) applications for PL 2100, for prescription and non-prescription uses, with this trial designed to address the regulatory requirements of both. 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 325 mg and 650 mg 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.
