Pharmacokinetic and Pharmacodynamic Study of a Novel Sublingual Aspirin Tablet

Cardiovascular Diseases Clinical Trial

Official title:

Pharmacokinetic and Pharmacodynamic Study of a Novel Sublingual Aspirin Tablet Compared to Conventional Oral Aspirin in Healthy Subjects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04792723
• Other study ID #: VG-BABE-19-01
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 5, 2021
• Est. completion date: September 1, 2021

Study information

• Verified date: March 2021
• Source: Vita Green Health Products Co. Ltd
• Contact: Rolley Lee
• Phone: +852 29035983
• Email: rolley.lee[@]vitagreen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: September 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Drug:
• Sublingual aspirin
Vita Green Health Products sublingual aspirin 80 mg tablet
• Oral aspirin
Synco (HK) oral aspirin 80mg tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vita Green Health Products Co. Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Peak plasma concentration of salicylic acid	Peak plasma concentration for sublingual versus oral aspirin 80mg	pre dose and up to 24 hour post dose
Secondary	Time to reach peak plasma concentration of salicylic acid	Tmax of sublingual versus oral aspirin 80mg	pre dose and up to 24 hour post dose
Secondary	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
Secondary	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
Secondary	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
Secondary	Platelet aggregation by impedance aggregometry	Differences in platelet aggregation with sublingual versus oral aspirin 80mg	pre dose and up to 360 minutes post dose