BioequivalencePhase 1NCT05055752
Randomized, Crossover Bioequivalence Study of PL-ASA Versus Immediate Release Aspirin in Healthy Volunteers.
A Phase 1 study testing Pharmaceutical-lipid aspirin (PL-ASA) in people with Bioequivalence, run by PLx Pharma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Pharmaceutical-lipid aspirin (PL-ASA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2020to 1 Oct 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Bioequivalence
- Being tested
- Pharmaceutical-lipid aspirin (PL-ASA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical-lipid aspirin (PL-ASA)Drug
Also called Immediate-release aspirin (IR-ASA)
Subjects receive the first drug, followed by a 7-day washout period, then receive the second drug.
| Study group | Role | What they receive |
|---|---|---|
| PL-ASA capsule, then IR-ASA tablet | Other | One PL-ASA 325 mg capsule, 14 day washout then one IR-ASA 325 mg tablet Receives: Drug: Pharmaceutical-lipid aspirin (PL-ASA) |
| IR-ASA tablet, then PL-ASA capsule | Other | One IR-ASA 325 mg tablet, 14 day washout, then one PL-ASA 325 mg capsule, Receives: Drug: Pharmaceutical-lipid aspirin (PL-ASA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence of single-dose acetylsalicylic acid PK of the PL-ASA formulation to IR-ASA in healthy volunteers at 325 mg dose level.
Bioequivalence using serum determinations of acetylsalicylic acid concentration
Measured: 24 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start7 May 2020
- Primary completion29 Jun 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, open-label, single dose 2-way crossover study in healthy volunteers
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- PLx Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055752
- Sponsor's protocol ID
- PL-ASA-009
- Status last verified
- Sep 2021
- First submitted
- 16 Sep 2021
- Last updated
- 27 Apr 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05055752
- Acronym / sponsor ID
- PL-ASA-009
- Conditions
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- PLx PharmaIndustry (pharma, biotech, devices)
- Study start
- 7 May 2020 (actual)
- Primary completion
- 29 Jun 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 24 Sep 2021 (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.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, open-label, single dose 2-way crossover study in healthy volunteers
| Arm | Type | Receives |
|---|---|---|
| PL-ASA capsule, then IR-ASA tablet | Other | Drug: Pharmaceutical-lipid aspirin (PL-ASA)One PL-ASA 325 mg capsule, 14 day washout then one IR-ASA 325 mg tablet |
| IR-ASA tablet, then PL-ASA capsule | Other | Drug: Pharmaceutical-lipid aspirin (PL-ASA)One IR-ASA 325 mg tablet, 14 day washout, then one PL-ASA 325 mg capsule, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (21 listed)
- 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;
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 |
|---|---|---|
| Pharmaceutical-lipid aspirin (PL-ASA)Also: Immediate-release aspirin (IR-ASA)Subjects receive the first drug, followed by a 7-day washout period, then receive the second drug. | Drug | IR-ASA tablet, then PL-ASA capsule, PL-ASA capsule, then IR-ASA tablet |
Primary outcome
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
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 27 Apr 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pharmaceutical-lipid aspirin (PL-ASA) in people with Bioequivalence, run by PLx Pharma at 1 site in United States.
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 8 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 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2022.