Randomized, Crossover Bioequivalence Study of PL-ASA Versus Immediate Release Aspirin in Healthy Volunteers.
Study Details
Study Description
Brief Summary
This trial is a randomized, actively-controlled, open-label, 2-way crossover bioequivalence study to determine PK parameters following treatment with test aspirin product (PL-ASA capsules) and reference aspirin product (IR-ASA tablets) administered at a single dose of 325 mg.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Detailed Description
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:
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PL-ASA capsule, IR-ASA tablet
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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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Other: PL-ASA capsule, then IR-ASA tablet One PL-ASA 325 mg capsule, 14 day washout then one IR-ASA 325 mg tablet |
Drug: Pharmaceutical-lipid aspirin (PL-ASA)
Subjects receive the first drug, followed by a 7-day washout period, then receive the second drug.
Other Names:
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Other: IR-ASA tablet, then PL-ASA capsule One IR-ASA 325 mg tablet, 14 day washout, then one PL-ASA 325 mg capsule, |
Drug: Pharmaceutical-lipid aspirin (PL-ASA)
Subjects receive the first drug, followed by a 7-day washout period, then receive the second drug.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Bioequivalence of single-dose acetylsalicylic acid PK of the PL-ASA formulation to IR-ASA in healthy volunteers at 325 mg dose level. [24 hours after dosing]
Bioequivalence using serum determinations of acetylsalicylic acid concentration
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female subjects at least 18 years of age without known acute or chronic medical conditions requiring treatment;
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If female, a negative pregnancy test and not nursing;
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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);
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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;
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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;
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A body mass index (BMI) between 18 to 32 kg/m2;
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Agrees to refrain from alcohol consumption for 48 hours prior to and 48 hours after drug administration; and
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Able and willing to provide written informed consent prior to the study.
Exclusion Criteria:
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Abnormal screening/baseline laboratory parameters deemed to be clinically significant by the Investigator;
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Positive urine alcohol and drug screen result;
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Use of any prescription medications other than hormone replacement therapy, thyroid replacement therapy, or oral contraceptive within 3 days prior to study drug administration;
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Use of antacid medications, including over-the-counter (OTC) products within 3 days prior to study drug administration;
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Use of dietary or herbal supplements containing salicylates, fish oil, or any vitamins within 2 weeks of study drug administration;
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Use of any of the following medications within 2 weeks prior to study drug administration:
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Non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin or aspirin-containing products and acetaminophen.
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Any anti-platelet agent, including clopidogrel, prasugrel, ticagrelor, ticlopidine, cangrelor, dipyridamole, cilostazol, vorapaxar, abciximab, eptifibatide, tirofiban, or triflusal.
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Any anti-coagulant agent, including warfarin, acenocoumarol, phenprocoumon, phenindione, rivaroxaban, dabigatran, apixaban, edoxaban, heparin, enoxaparin, fondaparinux, ximelagatran, argatroban, lepirudin, hirudin, or bivalirudin.
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Use of an investigational agent within the past 30 days prior to drug administration.
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Hypersensitivity or contraindications to aspirin, ibuprofen, or other NSAID;
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Soy allergy or sensitivity;
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History of:
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Gastrointestinal problems including ulcers, frequent indigestion, or frequent heartburn.
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Coronary disease, stroke, or congestive heart failure.
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Asthma, nasal polyps, or angioedema other than resolved childhood asthma.
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Kidney or liver disease.
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Thrombocytopenia, neutropenia, bleeding disorder, or history of non-trauma related hemorrhage.
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Chronic hypertension.
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Current enrollment in another investigational trial; or
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History of cancer within the last 5 years (except for skin cancer resolved by excision, or cervical cancer adequately treated).
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | PRA-EDS | Lenexa | Kansas | United States | 66219 |
Sponsors and Collaborators
- PLx Pharma
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PL-ASA-009