Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sublingual aspirin | Drug | Vita Green Health Products sublingual aspirin 80 mg tablet |
| |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rolley Lee | Contact | +852 29035983 | rolley.lee@vitagreen.com |
| Name | Affiliation | Role |
|---|---|---|
| Elaine Chow | Chinese University of Hong Kong | Principal Investigator |
Not provided
Not provided
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
Not provided
Not provided
single-dose, two-treatment, two-period, two-sequence, randomized, crossover design
Not provided
Not provided
Not provided
Not provided
| Oral aspirin |
| Drug |
Synco (HK) oral aspirin 80mg tablet |
|
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 |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |