Pharmacokinetic Studies

QRx conducted 3 Phase 1 PK studies in normal volunteers using MoxDuo® IR. In a crossover trial in 18 male and female volunteers that used the final formulation of MoxDuo IR, the proportionality kinetics of the lowest (3mg/2mg) and highest strength (12mg/8mg) capsules were compared. This study also evaluated the steady state kinetics seen after several days of dosing.

Results for morphine and its main glucuronide metabolites (M3G, M6G) and for oxycodone showed that the dose strengths produced dose proportional kinetics for AUC and Cmax. Plasma half lives were consistent with literature values for each analyte. In respect to repeat doses, the kinetic values for Area Under the Curve (AUC) and Maximum Plasma Concentration (Cmax) were predicted from the single dose data. The main conclusions are that the kinetics of the formulation being used in the pivotal trial is well behaved and that co-administration of a morphine:oxycodone combination product does not appear to affect the kinetics of each component.