Pharmacokinetic and Pharmacodynamic Study of a Novel Sublingual Aspirin Tablet
- Registration Number
- NCT04792723
- Lead Sponsor
- Vita Green Health Products Co. Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 24
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Healthy volunteer Oral aspirin Sublingual or oral aspirin 80mg tablet, single dose, two-treatment, two-period, two-sequence, randomized, crossover design, with washout 1-2 weeks Healthy volunteer Sublingual aspirin Sublingual or oral aspirin 80mg tablet, single dose, two-treatment, two-period, two-sequence, randomized, crossover design, with washout 1-2 weeks
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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
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
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