A Phase I, randomized, open-label single dose, 2-part, crossover bioequivalence study under fasted conditions to compare 100 mg capsules manufactured using the proposed commercial manufacturing process to the corresponding capsules which were utilized in the Phase III clinical study manufactured by a different process. In Period 1, 32 healthy volunteers will divided evenly and randomly assigned to receive 1 dose of 100 mg capsules from either the test product or reference product. In Period 2 the same patients in each cohort will cross over and receive 1 dose of the 100 mg from the other group. These healthy volunteers will receive 1 dose from each of the 100 mg capsules manufactured by both processes.~The single dose crossover study will have a minimum washout period of 14 days.
This is an open-label, Phase I single dose 2-part, crossover bioequivalence study under fasted conditions. The trial is designed to evaluate the pharmacokinetic parameters between single doses of 100mg ensartinib capsules manufactured by two difference processes.