Randomized, Crossover Bioequivalence Study of PL-ASA Versus Immediate Release Aspirin in Healthy Volunteers.

Healthy volunteers will be asked to sign informed consent prior to conduct any protocol specified activities at screening. A total of 20 eligible subjects will be randomized, in a fasted state, to 1 of 2 sequences of study drug administration (each study drug dose contains 325 mg aspirin) at 1:1 ratio:

• PL-ASA capsule, IR-ASA tablet
• IR-ASA tablet, PL-ASA capsule

After completion of the first treatment on Day 1 and following the 24 hours of sample collection, a minimum of a 7-day washout period will be required before all subjects are crossed over and receive treatment with the alternative compound; i.e., subject randomized to receive PL-ASA capsule as a first treatment will receive IR-ASA tablet as the second treatment, and vice-versa.

Inclusion criteria

• Male or female subjects at least 18 years of age without known acute or chronic medical conditions requiring treatment;
• If female, a negative pregnancy test and not nursing;
• If female and of childbearing potential, use of adequate birth control for the duration of the study (i.e., barrier methods such as female diaphragm or male condom; intrauterine devices, hormonal implants, pill, patch, shot, vaginal ring, etc.; total abstinence from heterosexual intercourse when it is in line with the preferred and usual lifestyle of the subject; vasectomized partner);
• Non-smoker, including no use of any smoking cessation nicotine-containing products (i.e., nicotine replacement therapy [patch, spray, inhaler, gum, lozenge, bupropion SR, clonidine and nortriptyline], e-cigarettes, etc.) for at least 3 months prior to screening;
• Consumes on average no more than 2 alcoholic drinks (1 drink is defined as approximately 12 oz of regular beer, 5 oz of wine, or 1.5 oz of hard liquor) per day for at least 30 days prior to screening;
• A body mass index (BMI) between 18 to 32 kg/m2;
• Agrees to refrain from alcohol consumption for 48 hours prior to and 48 hours after drug administration; and
• Able and willing to provide written informed consent prior to the study.

Exclusion criteria

• Abnormal screening/baseline laboratory parameters deemed to be clinically significant by the Investigator;
• Positive urine alcohol and drug screen result;
• Use of any prescription medications other than hormone replacement therapy, thyroid replacement therapy, or oral contraceptive within 3 days prior to study drug administration;
• Use of antacid medications, including over-the-counter (OTC) products within 3 days prior to study drug administration;
• Use of dietary or herbal supplements containing salicylates, fish oil, or any vitamins within 2 weeks of study drug administration;
• Use of any of the following medications within 2 weeks prior to study drug administration:

• Non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin or aspirin-containing products and acetaminophen.
• Any anti-platelet agent, including clopidogrel, prasugrel, ticagrelor, ticlopidine, cangrelor, dipyridamole, cilostazol, vorapaxar, abciximab, eptifibatide, tirofiban, or triflusal.
• Any anti-coagulant agent, including warfarin, acenocoumarol, phenprocoumon, phenindione, rivaroxaban, dabigatran, apixaban, edoxaban, heparin, enoxaparin, fondaparinux, ximelagatran, argatroban, lepirudin, hirudin, or bivalirudin.
• Use of an investigational agent within the past 30 days prior to drug administration.
• Hypersensitivity or contraindications to aspirin, ibuprofen, or other NSAID;
• Soy allergy or sensitivity;
• History of:

• Gastrointestinal problems including ulcers, frequent indigestion, or frequent heartburn.
• Coronary disease, stroke, or congestive heart failure.
• Asthma, nasal polyps, or angioedema other than resolved childhood asthma.
• Kidney or liver disease.
• Thrombocytopenia, neutropenia, bleeding disorder, or history of non-trauma related hemorrhage.
• Chronic hypertension.
• Current enrollment in another investigational trial; or
• History of cancer within the last 5 years (except for skin cancer resolved by excision, or cervical cancer adequately treated).