Phase 1 Study of PA32540 for Platelet Inhibition

POZEN announced results from its Phase 1 study of PA32540 (aspirin/omeprazole). The randomized, open-label, two-arm crossover study enrolled 30 healthy patients who were administered one of two regimens:
  • PA32540 in the morning plus Plavix 300mg (clopidogrel; Bristol-Myers Squibb and sanofi) over 10 hours later on Day 1, and PA32540 in the morning plus Plavix 75mg 10 hours later on Days 2–7 or,
  • Enteric-coated aspirin 81mg plus Plavix 300mg plus Prilosec (omeprazole; AstraZeneca) 40mg all in the morning on Day 1 followed by enteric-coated aspirin 81mg plus Plavix 75mg plus Prilosec 40mg all in the morning on Days 2–7.
Data demonstrated that PA32540 in the morning plus Plavix 10 hours later resulted in a significantly greater inhibition of platelet aggregation than enteric-coated aspirin plus Prilosec plus Plavix all dosed in the morning.

PA32540 is a novel coordinated-delivery tablet of enteric-coated aspirin 325mg and immediate-release omeprazole 40mg being studied for the inhibition of platelet aggregation.

For more information call (919) 913-1030 or visit www.pozen.com.