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Trial record 70 of 87 for:    ASPIRIN AND thromboxane

Pharmacokinetic and Pharmacodynamic Assessment of a Novel, Pharmaceutical Lipid-Aspirin Complex

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ClinicalTrials.gov Identifier: NCT04008979
Recruitment Status : Completed
First Posted : July 4, 2019
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
PLx Pharma

Brief Summary:
Prospective, Randomized, Crossover, Bioequivalence study

Condition or disease Intervention/treatment Phase
Bioequivalence Drug: Aspirin Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 32 subjects to be randomized to treatment with either immediate release aspirin or PL-ASA at one of two doses (325 mg or 650 mg) administered orally. After completion of the first treatment and a minimum of a two week washout period(14-17 days) subjects are to cross over and receive treatment with the alternative compound at the same dose level.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacokinetic and Pharmacodynamic Assessment of a Novel, Pharmaceutical Lipid-Aspirin Complex
Actual Study Start Date : February 11, 2008
Actual Primary Completion Date : June 10, 2008
Actual Study Completion Date : June 10, 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: PL-ASA 325 mg
Novel aspirin formulation being tested
Drug: Aspirin
Aspirin - lipid complex

Active Comparator: IR 325 mg
Immediate release aspirin
Drug: Aspirin
Aspirin - lipid complex

Experimental: PL-ASA-650
Novel aspirin formulation being tested
Drug: Aspirin
Aspirin - lipid complex

Active Comparator: IR 650
Immediate release aspirin
Drug: Aspirin
Aspirin - lipid complex




Primary Outcome Measures :
  1. Bioequivalence of PL-ASA and Immediate Release Aspirin AUC0-T [ Time Frame: twenty four hours ]
    Assess for bioequivalence at 325 mg and 650 mg dose levels AUC0-T of the metabolite salicylic acid

  2. Bioequivalence of PL-ASA and Immediate Release Aspirin AUC0-∞ [ Time Frame: 24 hours ]
    Assess for bioequivalence at 325 mg and 650 mg dose levels AUC0-∞ of the metabolite salicylic acid

  3. Bioequivalence of PL-ASA and Immediate Release Aspirin CMAX [ Time Frame: 24 hours ]
    Assess for bioequivalence at 325 mg and 650 mg dose levels CMAX of the metabolite salicylic acid

  4. Bioequivalence of PL-ASA and Immediate Release Aspirin TMAX [ Time Frame: 24 hours ]
    Assess for bioequivalence at 325 mg and 650 mg dose levels TMAX of the metabolite salicylic acid

  5. Bioequivalence of PL-ASA and Immediate Release Aspirin AUC0-24 [ Time Frame: 24 hours ]
    Assess for bioequivalence at 325 mg and 650 mg dose levels AUC0-24 of the percent inhibition of serum Thromboxane B2

  6. Bioequivalence of PL-ASA and Immediate Release Aspirin TMAX STB2 [ Time Frame: 24 hours ]
    Assess for bioequivalence at 325 mg and 650 mg dose levels TMAX of the percent inhibition of serum Thromboxane B2



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • If female and of childbearing potential, subject has a negative pregnancy test and is not nursing.
  • If female and of childbearing potential, subject is using adequate birth control for the duration of the study.
  • Subject is able to understand and comply with study procedures.
  • Subject is a non-smoker.
  • Subject consumes no more than 1 alcoholic drink per day.
  • Subject agrees to refrain from alcohol consumption for 48 hours prior to each drug administration and 48 hours after each drug administration.
  • Subject is able and willing to provide written informed consent prior to any study procedures being performed.

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:

    • NSAIDs or other medications for pain, including aspirin or aspirin containing products and acetaminophen (see Appendix B of protocol in Appendix 16.1.1)
    • Proton pump inhibitors, including Prilosec®, Prevacid®, Aciphex®, Protonix®, or Nexium®
    • H-2 blockers, including Tagamet®, Zantac®, Axid®, or Pepcid®
    • Any antiplatelet agent, including Plavix®, Ticlid®, Pletal®, ReoPro®, Integrilin®, Aggrastat®, or Persantine®
    • Any anti-coagulant, including Coumadin®, Acenocoumarol, Phenprocoumon, Phenindione, Heparin, Exanta®, Argatroban, Lepirudin, Hirudin or Bivalirudin
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04008979


Sponsors and Collaborators
PLx Pharma
Investigators
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Study Director: Upendra Marathi, PhD PLx Pharma

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: PLx Pharma
ClinicalTrials.gov Identifier: NCT04008979     History of Changes
Other Study ID Numbers: 74,290
First Posted: July 4, 2019    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics