Clinical trial NCT04792723: Pharmacokinetic and Pharmacodynamic Study of a Novel Sublingual Aspirin Tablet
Official title: Pharmacokinetic and Pharmacodynamic Study of a Novel Sublingual Aspirin Tablet Compared to Conventional Oral Aspirin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cardiovascular Diseases
Lead sponsor: Vita Green Health Products Co. Ltd
Sponsor class: INDUSTRY
First posted: 2021-03-11
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-dose, two-treatment, two-period, two-sequence, randomized, crossover design
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Plasma-concentration time data of salicylic acid
timeFrame: pre dose and up to 24 hour post dose
Secondary outcomes:
measure: Peak plasma concentration of salicylic acid
timeFrame: pre dose and up to 24 hour post dose
measure: Time to reach peak plasma concentration of salicylic acid
timeFrame: pre dose and up to 24 hour post dose
measure: Terminal phase elimination rate constant of salicylic acid
timeFrame: pre dose and up to 24 hour post dose
measure: Terminal elimination half-life of salicylic acid
timeFrame: pre dose and up to 24 hour post dose
measure: Plasma concentration time data of thromboxane B2
timeFrame: pre dose and up to 24 hour post dose
measure: Platelet aggregation by impedance aggregometry
timeFrame: pre dose and up to 360 minutes post dose
Other outcomes:
Locations:
Study officials:
affiliation: Chinese University of Hong Kong
name: Elaine Chow
role: PRINCIPAL_INVESTIGATOR
References: