Methods
In Part 2 of the study, the following adaptations were made to the study methodology:
1.0 mL of 0.9%w/v saline solution was accurately pipetted into a deactivated glass HPLC vial. An accurately pipetted aliquot of OXY injection solution was added to the saline solution in the HPLC vial and the solution vortex mixed. The volume of OXY injection solution added was 20µL for experiments using OXY 1 (5 IU/mL) and 10µL for OXY 2 (10 IU/mL) to accommodate the different concentration strengths of the two products. Following the addition of OXY, a 100µL aliquot of TXA injection solution was accurately measured into the HPLC vial and the solution vortex mixed. This provides solution concentrations for both active compounds comparable to those used in Part 1 of the study. On completion of mixing, the HPLC vial was placed immediately into the LC-MS equipment and the assay process started with samples analysed at t=0 minutes and every 10 minutes thereafter over a 1-hour period.
In total, 19 combinations of OXY and TXA in saline solution were evaluated. All 18 TXA products were assessed in combination with the OXY 1 product, while a combination of TXA 8 and OXY 2 was assessed to evaluate a specific combination of interest to the E-MOTIVE Trial.