BioequivalencePhase 1NCT04008979
Pharmacokinetic and Pharmacodynamic Assessment of a Novel, Pharmaceutical Lipid-Aspirin Complex
A Phase 1 study testing Aspirin in people with Bioequivalence, run by PLx Pharma.
Trial summary
Prospective, Randomized, Crossover, Bioequivalence study Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 11 Feb 2008to 10 Jun 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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®
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- 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
About this study
Prospective, Randomized, Crossover, Bioequivalence study
Read the 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.
- Conditions
- Bioequivalence
- Being tested
- Aspirin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Aspirin - lipid complex
| Study group | Role | What they receive |
|---|---|---|
| PL-ASA 325 mg | Experimental | Novel aspirin formulation being tested Receives: Drug: Aspirin |
| IR 325 mg | Active comparator | Immediate release aspirin Receives: Drug: Aspirin |
| PL-ASA-650 | Experimental | Novel aspirin formulation being tested Receives: Drug: Aspirin |
| IR 650 | Active comparator | Immediate release aspirin Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence of PL-ASA and Immediate Release Aspirin AUC0-T
Assess for bioequivalence at 325 mg and 650 mg dose levels AUC0-T of the metabolite salicylic acid
Measured: twenty four hours
Bioequivalence of PL-ASA and Immediate Release Aspirin AUC0-∞
Assess for bioequivalence at 325 mg and 650 mg dose levels AUC0-∞ of the metabolite salicylic acid
Measured: 24 hours
Bioequivalence of PL-ASA and Immediate Release Aspirin CMAX
Assess for bioequivalence at 325 mg and 650 mg dose levels CMAX of the metabolite salicylic acid
Measured: 24 hours
Bioequivalence of PL-ASA and Immediate Release Aspirin TMAX
Assess for bioequivalence at 325 mg and 650 mg dose levels TMAX of the metabolite salicylic acid
Measured: 24 hours
Bioequivalence of PL-ASA and Immediate Release Aspirin AUC0-24
Assess for bioequivalence at 325 mg and 650 mg dose levels AUC0-24 of the percent inhibition of serum Thromboxane B2
Measured: 24 hours
Bioequivalence of PL-ASA and Immediate Release Aspirin TMAX STB2
Assess for bioequivalence at 325 mg and 650 mg dose levels TMAX of the percent inhibition of serum Thromboxane B2
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start11 Feb 2008
- Primary completion10 Jun 2008
- Study completion10 Jun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BioequivalenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- PLx Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Upendra Marathi, PhD, Study director, PLx Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008979
- Sponsor's protocol ID
- 74,290
- Status last verified
- Jul 2019
- First submitted
- 2 Jul 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Angiolillo DJ, Bhatt DL, Lanza F, Cryer B, Dong JF, Jeske W, Zimmerman RR, von Chong E, Prats J, Deliargyris EN, Marathi U. Pharmacokinetic/pharmacodynamic assessment of a novel, pharmaceutical lipid-aspirin complex: results of a randomized, crossover, bioequivalence study. J Thromb Thrombolysis. 2019 Nov;48(4):554-562. doi: 10.1007/s11239-019-01933-7.
PubMed 31420787
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic and Pharmacodynamic Assessment of a Novel, Pharmaceutical Lipid-Aspirin Complex
- ClinicalTrials.gov ID
- NCT04008979
- Acronym / sponsor ID
- 74,290
- Conditions
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- PLx PharmaIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2008 (actual)
- Primary completion
- 10 Jun 2008 (actual)
- Study completion
- 10 Jun 2008 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, Randomized, Crossover, Bioequivalence study
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| PL-ASA 325 mg | Experimental | Drug: AspirinNovel aspirin formulation being tested |
| IR 325 mg | Active comparator | Drug: AspirinImmediate release aspirin |
| PL-ASA-650 | Experimental | Drug: AspirinNovel aspirin formulation being tested |
| IR 650 | Active comparator | Drug: AspirinImmediate release aspirin |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (21 listed)
- 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:
- Subject has used an investigational agent within the past 30 days.
- Subject has hypersensitivity or contraindications to aspirin, ibuprofen, or other NSAID.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinAspirin - lipid complex | Drug | IR 325 mg, IR 650, PL-ASA 325 mg, PL-ASA-650 |
Primary outcome
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Derived from this study: PubMed 31420787Angiolillo DJ, Bhatt DL, Lanza F, Cryer B, Dong JF, Jeske W, Zimmerman RR, von Chong E, Prats J, Deliargyris EN, Marathi U. Pharmacokinetic/pharmacodynamic assessment of a novel, pharmaceutical lipid-aspirin complex: results of a randomized, crossover, bioequivalence study. J Thromb Thrombolysis. 2019 Nov;48(4):554-562. doi: 10.1007/s11239-019-01933-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Upendra Marathi, PhD study director
PLx Pharma
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aspirin in people with Bioequivalence, run by PLx Pharma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioequivalence of PL-ASA and Immediate Release Aspirin AUC0-T (time frame: twenty four hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04008979, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.