Pharmacokinetic and Pharmacodynamic Study of a Novel Sublingual Aspirin Tablet

Study Overview
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Brief Summary
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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.

Official Title
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Pharmacokinetic and Pharmacodynamic Study of a Novel Sublingual Aspirin Tablet Compared to Conventional Oral Aspirin in Healthy Subjects

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Drug: Sublingual aspirin
* Drug: Oral aspirin


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: single-dose, two-treatment, two-period, two-sequence, randomized, crossover design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy volunteer<br>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<br>* Vita Green Health Products sublingual aspirin 80 mg tablet<br>Drug: Oral aspirin<br>* Synco (HK) oral aspirin 80mg tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | pre dose and up to 24 hour post dose | 

Secondary Outcome Measures

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