- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05055752
Randomized, Crossover Bioequivalence Study of PL-ASA Versus Immediate Release Aspirin in Healthy Volunteers.
A Randomized, Actively-Controlled, Crossover Bioequivalence Study of a Novel Pharmaceutical Lipid-Aspirin Complex Formulation at 325 mg Dose Versus Immediate Release Aspirin in Healthy Volunteers
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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Kansas
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Lenexa, Kansas, United States, 66219
- PRA-EDS
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: PL-ASA capsule, then IR-ASA tablet
One PL-ASA 325 mg capsule, 14 day washout then one IR-ASA 325 mg tablet
|
Subjects receive the first drug, followed by a 7-day washout period, then receive the second drug.
Other Names:
|
Other: IR-ASA tablet, then PL-ASA capsule
One IR-ASA 325 mg tablet, 14 day washout, then one PL-ASA 325 mg capsule,
|
Subjects receive the first drug, followed by a 7-day washout period, then receive the second drug.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bioequivalence of single-dose acetylsalicylic acid PK of the PL-ASA formulation to IR-ASA in healthy volunteers at 325 mg dose level.
Time Frame: 24 hours after dosing
|
Bioequivalence using serum determinations of acetylsalicylic acid concentration
|
24 hours after dosing
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
Other Study ID Numbers
- PL-ASA-009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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