A randomized, open-label, 2-way crossover pharmacodynamic and pharmacokinetic study of a novel pharmaceutical lipid-aspirin complex formulation (PL-ASA) at an 81 mg dose

This study is a randomized, open-label, 2-way crossover study to assess pharmacodyamic and pharmacokinetic profiles following treatment with PL-ASA and EC-ASA administered under fasting condition at a single dose of 81 mg among the volunteers aged 50 to 75 years.

Inclusion Criteria:

• Male or female non-smoking subjects between the ages of 18 to 75 years inclusive, without known medical conditions requiring treatment
• Consumes on average no more than 2 alcoholic drinks per day for 30 days prior to study

Exclusion Criteria:

• Abnormal baseline laboratory results
• Current prescribed use of aspirin, warfarin or other anticoagulants
• Use of other specific medications within 2 weeks of study start
• History of certain medical conditions
• Subject's platelets are unresponsive to arachidonic acid, as defined as <60% of aggregation as measured by light transmittance aggregometry