Pharmacokinetic and Pharmacodynamic Study of a Novel Sublingual Aspirin Tablet

NCT ID: NCT04792723

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-05
• Study Completion Date: 2021-09-01

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.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Healthy volunteer

Sublingual or oral aspirin 80mg tablet, single dose, two-treatment, two-period, two-sequence, randomized, crossover design, with washout 1-2 weeks

Group Type: EXPERIMENTAL

Sublingual aspirin

Intervention Type: DRUG

Vita Green Health Products sublingual aspirin 80 mg tablet

Oral aspirin

Intervention Type: DRUG

Synco (HK) oral aspirin 80mg tablet

Interventions

Sublingual aspirin

Vita Green Health Products sublingual aspirin 80 mg tablet

Intervention Type: DRUG

Oral aspirin

Synco (HK) oral aspirin 80mg tablet

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Vita Green Health Products Co. Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Dr. Elaine Chow

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elaine Chow

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Central Contacts

Rolley Lee

Role: CONTACT

rolley.lee@vitagreen.com

+852 29035983

Other Identifiers

VG-BABE-19-01

Identifier Type: -

Identifier Source: org_study_id