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Pharmacokinetic and Pharmacodynamic Study of a Novel Sublingual Aspirin Tablet

Phase 1
Conditions
Cardiovascular Diseases
Interventions
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Healthy volunteerOral aspirinSublingual or oral aspirin 80mg tablet, single dose, two-treatment, two-period, two-sequence, randomized, crossover design, with washout 1-2 weeks
Healthy volunteerSublingual aspirinSublingual or oral aspirin 80mg tablet, single dose, two-treatment, two-period, two-sequence, randomized, crossover design, with washout 1-2 weeks
Primary Outcome Measures
NameTimeMethod
Plasma-concentration time data of salicylic acidpre 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
NameTimeMethod
Terminal phase elimination rate constant of salicylic acidpre 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 B2pre 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 acidpre dose and up to 24 hour post dose

Tmax of sublingual versus oral aspirin 80mg

Terminal elimination half-life of salicylic acidpre dose and up to 24 hour post dose

Terminal elimination half-life of sublingual versus oral aspirin 80mg

Platelet aggregation by impedance aggregometrypre dose and up to 360 minutes post dose

Differences in platelet aggregation with sublingual versus oral aspirin 80mg

Peak plasma concentration of salicylic acidpre dose and up to 24 hour post dose

Peak plasma concentration for sublingual versus oral aspirin 80mg

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