Status unknownNCT04792723Updated Mar 11, 2021

Pharmacokinetic and Pharmacodynamic Study of a Novel Sublingual Aspirin Tablet

A Phase 1 interventional study of Sublingual aspirin and Oral aspirin in Cardiovascular Diseases, sponsored by Vita Green Health Products Co. Ltd. Status unknown. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-11.

Sponsored by Vita Green Health Products Co. Ltd · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Phase 1
Study type: Interventional
Enrollment: 24
Allocation: Not applicable
Ages: 18 Years to 55 Years
Sex: Male

Study 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. Ltd, Hong Kong and the reference product is oral aspirin 80mg tablet manufactured by Synco (HK) Ltd, Hong Kong.

Conditions studied

Cardiovascular Diseases

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In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's planned enrollment of 24 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

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Lead sponsor

This is the only study on the registry with Vita Green Health Products Co. Ltd as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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
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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 24 participants (estimated)

Study arms

Experimental
Healthy volunteer
Sublingual or oral aspirin 80mg tablet, single dose, two-treatment, two-period, two-sequence, randomized, crossover design, with washout 1-2 weeks
Drug: Sublingual aspirin · Drug: Oral aspirin

Interventions

DrugSublingual aspirin
Vita Green Health Products sublingual aspirin 80 mg tablet
DrugOral aspirin
Synco (HK) oral aspirin 80mg tablet

What researchers measure

Primary outcomes

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
Time frame: pre dose and up to 24 hour post dose

Secondary outcomes

Peak plasma concentration of salicylic acid
Peak plasma concentration for sublingual versus oral aspirin 80mg
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: pre dose and up to 24 hour post dose
Platelet aggregation by impedance aggregometry
Differences in platelet aggregation with sublingual versus oral aspirin 80mg
Time frame: pre dose and up to 360 minutes post dose

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04792723
Lead sponsor: Vita Green Health Products Co. Ltd
Responsible party: Dr. Elaine Chow (Clinical Assistant Professor, Chinese University of Hong Kong) — Principal investigator
First posted: Mar 11, 2021
Start date: Mar 5, 2021 (estimated)
Primary completion: Jul 1, 2021 (estimated)
Completion: Sep 1, 2021 (estimated)
Last update: Mar 11, 2021

Study contacts

Rolley Lee

Contact

rolley.lee@vitagreen.com

+852 29035983

Elaine Chow

principal investigator · Chinese University of Hong Kong

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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