Cardiovascular DiseasesPhase 1NCT04792723
Pharmacokinetic and Pharmacodynamic Study of a Novel Sublingual Aspirin Tablet
A Phase 1 study testing Sublingual aspirin and Oral aspirin in people with Cardiovascular Diseases, run by Vita Green Health Products Co. Ltd.
Trial summary
The objective of the study is to compare the pharmacokinetics and pharmacodynamics of a new sublingual formulation of aspirin with that of oral aspirin when administered to healthy volunteers under fasting conditions. The test product is sublingual aspirin 80 mg manufactured by Vita Green Health Products Co. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Sublingual aspirin and Oral aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 5 Mar 2021to 1 Sep 2021
- 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 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, 18 to 55 years of age
- Body mass index between 18-27kg/m2
- Accessible vein for blood sampling
- High probability for compliance and completion of the study
- No significant abnormalities in general physical examination
- Subjects must agree to take effective contraceptive methods to prevent his partner pregnant during the time of first dose of study medication until one week of last dose administration
Who cannot join
- History of hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to screening
- Clinically relevant abnormality in physical examination, ECG evaluation, urine test, blood chemistry or haematological test at the discretion of the investigator
- Positive results for hepatitis B at screening
- Moderate smoker (on average more than 2 cigarettes a day within 1 month prior to the start of first dosing)
- Moderate consumption of alcohol (on average more than one drink per day within 1 month prior to start of first dosing)
- Blood donation of more than 350 ml within 4 weeks prior to start of first drug dosing
Show all 9Show fewer
- Treatment of aspirin within 4 weeks before first dosing
- Volunteer in any other clinical drug study within 2 months prior to start of first dosing
- Hypersensitivity to aspirin or other drug in its class
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pharmacokinetic and Pharmacodynamic Study of a Novel Sublingual Aspirin Tablet Compared to Conventional Oral Aspirin in Healthy Subjects
The objective of the study is to compare the pharmacokinetics and pharmacodynamics of a new sublingual formulation of aspirin with that of oral aspirin when administered to healthy volunteers under fasting conditions. The test product is sublingual aspirin 80 mg manufactured by Vita Green Health Products Co. Ltd, Hong Kong and the reference product is oral aspirin 80mg tablet manufactured by Synco (HK) Ltd, Hong Kong.
- Conditions
- Cardiovascular Diseases
- Being tested
- Sublingual aspirin, Oral aspirin
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublingual aspirinDrug
Vita Green Health Products sublingual aspirin 80 mg tablet
Oral aspirinDrug
Synco (HK) oral aspirin 80mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteer | Experimental | Sublingual or oral aspirin 80mg tablet, single dose, two-treatment, two-period, two-sequence, randomized, crossover design, with washout 1-2 weeks Receives: Drug: Sublingual aspirin; Drug: Oral aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma-concentration time data of salicylic acid
area under the plasma concentration-time curve from time zero to last measurable concentration time point for sublingual versus oral aspirin 80mg
Measured: pre dose and up to 24 hour post dose
Secondary outcomes (6)
Peak plasma concentration of salicylic acid
Peak plasma concentration for sublingual versus oral aspirin 80mg
Measured: pre dose and up to 24 hour post dose
Time to reach peak plasma concentration of salicylic acid
Tmax of sublingual versus oral aspirin 80mg
Measured: pre dose and up to 24 hour post dose
Terminal phase elimination rate constant of salicylic acid
Terminal phase elimination rate constant of sublingual versus oral aspirin 80mg
Measured: pre dose and up to 24 hour post dose
Terminal elimination half-life of salicylic acid
Terminal elimination half-life of sublingual versus oral aspirin 80mg
Measured: pre dose and up to 24 hour post dose
Plasma concentration time data of thromboxane B2
Area under the curve for sublingual versus oral aspirin 80mg
Measured: pre dose and up to 24 hour post dose
Platelet aggregation by impedance aggregometry
Differences in platelet aggregation with sublingual versus oral aspirin 80mg
Measured: pre dose and up to 360 minutes post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start5 Mar 2021 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- single-dose, two-treatment, two-period, two-sequence, randomized, crossover design
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vita Green Health Products Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dr. Elaine Chow, Chinese University of Hong Kong
- Investigators
- Elaine Chow, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792723
- Sponsor's protocol ID
- VG-BABE-19-01
- Status last verified
- Mar 2021
- First submitted
- 4 Mar 2021
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic and Pharmacodynamic Study of a Novel Sublingual Aspirin Tablet Compared to Conventional Oral Aspirin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04792723
- Acronym / sponsor ID
- VG-BABE-19-01
- Conditions
- Cardiovascular Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Vita Green Health Products Co. LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2021 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 11 Mar 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.
The objective of the study is to compare the pharmacokinetics and pharmacodynamics of a new sublingual formulation of aspirin with that of oral aspirin when administered to healthy volunteers under fasting conditions. The test product is sublingual aspirin 80 mg manufactured by Vita Green Health Products Co. Ltd, Hong Kong and the reference product is oral aspirin 80mg tablet manufactured by Synco (HK) Ltd, Hong Kong.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-dose, two-treatment, two-period, two-sequence, randomized, crossover design
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteer | Experimental | Drug: Sublingual aspirin, Drug: Oral aspirinSublingual or oral aspirin 80mg tablet, single dose, two-treatment, two-period, two-sequence, randomized, crossover design, with washout 1-2 weeks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male, 18 to 55 years of age
- Body mass index between 18-27kg/m2
- Accessible vein for blood sampling
- High probability for compliance and completion of the study
- No significant abnormalities in general physical examination
Key exclusion criteria (9 listed)
- History of hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to screening
- Clinically relevant abnormality in physical examination, ECG evaluation, urine test, blood chemistry or haematological test at the discretion of the investigator
- Positive results for hepatitis B at screening
- Moderate smoker (on average more than 2 cigarettes a day within 1 month prior to the start of first dosing)
- Moderate consumption of alcohol (on average more than one drink per day within 1 month prior to start of first dosing)
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 |
|---|---|---|
| Sublingual aspirinVita Green Health Products sublingual aspirin 80 mg tablet | Drug | Healthy volunteer |
| Oral aspirinSynco (HK) oral aspirin 80mg tablet | Drug | Healthy volunteer |
Primary outcome
Plasma-concentration time data of salicylic acid
Time frame: pre dose and up to 24 hour post dose
area under the plasma concentration-time curve from time zero to last measurable concentration time point for sublingual versus oral aspirin 80mg
6 secondary outcomes
Peak plasma concentration of salicylic acid
Time frame: pre dose and up to 24 hour post dose
Time to reach peak plasma concentration of salicylic acid
Time frame: pre dose and up to 24 hour post dose
Terminal phase elimination rate constant of salicylic acid
Time frame: pre dose and up to 24 hour post dose
Terminal elimination half-life of salicylic acid
Time frame: pre dose and up to 24 hour post dose
Plasma concentration time data of thromboxane B2
Time frame: pre dose and up to 24 hour post dose
Platelet aggregation by impedance aggregometry
Time frame: pre dose and up to 360 minutes post dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
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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.
Elaine Chow principal investigator
Chinese University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sublingual aspirin and Oral aspirin in people with Cardiovascular Diseases, run by Vita Green Health Products Co. Ltd.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 11 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rolley Lee (+852 29035983, rolley.lee@vitagreen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma-concentration time data of salicylic acid (time frame: pre dose and up to 24 hour post dose). 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 11 Mar 2021.