- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04008979
Pharmacokinetic and Pharmacodynamic Assessment of a Novel, Pharmaceutical Lipid-Aspirin Complex
July 3, 2019 updated by: PLx Pharma
Prospective, Randomized, Crossover, Bioequivalence study
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PL-ASA 325 mg
Novel aspirin formulation being tested
|
Aspirin - lipid complex
|
Active Comparator: IR 325 mg
Immediate release aspirin
|
Aspirin - lipid complex
|
Experimental: PL-ASA-650
Novel aspirin formulation being tested
|
Aspirin - lipid complex
|
Active Comparator: IR 650
Immediate release aspirin
|
Aspirin - lipid complex
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
twenty four hours
|
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
|
24 hours
|
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
|
24 hours
|
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
|
24 hours
|
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
|
24 hours
|
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
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Upendra Marathi, PhD, PLx Pharma
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 11, 2008
Primary Completion (Actual)
June 10, 2008
Study Completion (Actual)
June 10, 2008
Study Registration Dates
First Submitted
July 2, 2019
First Submitted That Met QC Criteria
July 3, 2019
First Posted (Actual)
July 5, 2019
Study Record Updates
Last Update Posted (Actual)
July 5, 2019
Last Update Submitted That Met QC Criteria
July 3, 2019
Last Verified
July 1, 2019
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
- 74,290
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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