Cardiovascular Diseases
Conditions
Brief 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.
Interventions
DRUGSublingual aspirin
Vita Green Health Products sublingual aspirin 80 mg tablet
DRUGOral aspirin
Synco (HK) oral aspirin 80mg tablet
Sponsors
Vita Green Health Products Co. Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
single-dose, two-treatment, two-period, two-sequence, randomized, crossover design
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male, 18 to 55 years of age 2. Body mass index between 18-27kg/m2 3. Accessible vein for blood sampling 4. High probability for compliance and completion of the study 5. No significant abnormalities in general physical examination 6. 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
1. History of hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to screening 2. Clinically relevant abnormality in physical examination, ECG evaluation, urine test, blood chemistry or haematological test at the discretion of the investigator 3. Positive results for hepatitis B at screening 4. Moderate smoker (on average more than 2 cigarettes a day within 1 month prior to the start of first dosing) 5. Moderate consumption of alcohol (on average more than one drink per day within 1 month prior to start of first dosing) 6. Blood donation of more than 350 ml within 4 weeks prior to start of first drug dosing 7. Treatment of aspirin within 4 weeks before first dosing 8. Volunteer in any other clinical drug study within 2 months prior to start of first dosing 9. Hypersensitivity to aspirin or other drug in its class
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma-concentration time data of salicylic acid | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Platelet aggregation by impedance aggregometry | pre dose and up to 360 minutes post dose | Differences in platelet aggregation with sublingual versus oral aspirin 80mg |
| Peak plasma concentration of salicylic acid | pre dose and up to 24 hour post dose | Peak plasma concentration for sublingual versus oral aspirin 80mg |
| Plasma concentration time data of thromboxane B2 | pre dose and up to 24 hour post dose | Area under the curve for sublingual versus oral aspirin 80mg |
| Terminal phase elimination rate constant of salicylic acid | pre dose and up to 24 hour post dose | Terminal phase elimination rate constant of sublingual versus oral aspirin 80mg |
| Terminal elimination half-life of salicylic acid | pre dose and up to 24 hour post dose | Terminal elimination half-life of sublingual versus oral aspirin 80mg |
| Time to reach peak plasma concentration of salicylic acid | pre dose and up to 24 hour post dose | Tmax of sublingual versus oral aspirin 80mg |
Contacts
Primary ContactRolley Lee
Outcome results
None listed