Pharmacokinetic and Pharmacodynamic Assessment of a Novel, Pharmaceutical Lipid-Aspirin Complex
Pharmacokinetic and Pharmacodynamic Assessment of a Novel, Pharmaceutical Lipid-Aspirin Complex
Prospective, Randomized, Crossover, Bioequivalence study
Active-control crossover study randomizing 32 healthy volunteers to receive one of two dose levels, 325 mg or 650 mg, of either PL-ASA or immediate release aspirin within a two week washout period between treatments. The primary objectives are to assess PK and PD bioequivalence and safety over a twenty four hour period for PL-ASA and immediate release aspirin at 325 mg and 650 mg dose strengths.
Inclusion Criteria:
Exclusion Criteria:
Subject has abnormal screening/baseline laboratory parameters deemed to be clinically significant by the Investigator.
Subject has taken any prescription medications other than hormone replacement therapy or thyroid replacement hormones within 3 days prior to drug administration.
Subject has taken any of the following medications within 2 weeks prior to study entry:
Subject has used an investigational agent within the past 30 days.
Subject has hypersensitivity or contraindications to aspirin, ibuprofen, or other NSAID.
Subject has sensitivity to lecithin.
Subject has a history of gastrointestinal problems including ulcers, frequent indigestion, or heartburn.
Subject has a history of stroke, myocardial infarction, or congestive heart failure.
Subject has a history of asthma, other bronchospastic activity, nasal polyps, or angioedema other than resolved childhood asthma.
Subject has a history of kidney or liver disease.
Subject has a history of thrombocytopenia, neutropenia, or bleeding disorder.
Subject has a history of coronary arterial bypass.
Subject has a history of non-trauma related hemorrhage.
Subject has a history of chronic hypertension.
Subject is currently enrolled in another investigational trial.
Subject's platelets are unresponsive to arachidonic acid