Additional Relevant Details In the pilot bioavailability study, 42 subjects were randomized to receive a single dose of one of five PUR0200 formulations or the reference product in a 7-period crossover design to assess the pharmacokinetics, safety and tolerability of PUR0200 and its relative bioavailability to the reference product. The completed study aimed at defining the relationship of PUR0200 formulation characteristics to the pharmacokinetic profile of the drug to establish formulation parameters for further development towards formal pharmacokinetic bioequivalence based on peak plasma concentrations (Cmax) and plasma concentrations over time (Area under the curve; AUC).Clinical highlights from the study include:

• Pharmacokinetics. PUR0200 kinetics were similar across all doses and formulations tested, with dose proportional increases in exposure for similarly sized formulations and the relationships between formulation parameters and bioavailabilty were defined. Plasma pharmacokinetic measures were comparable between selected PUR0200 formulations and the reference product.
• Safety and tolerability. There were no serious adverse events and the safety profile of PUR0200 was comparable to that of the reference product. Of the 42 enrolled subjects, 41 completed all dosing periods.