Pharmacokinetic and Pharmacodynamic Study of a Novel Sublingual Aspirin Tablet

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Drug: Sublingual aspirin; Drug: Oral aspirin

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Rolley Lee; Phone Number: +852 29035983; Email: rolley.lee@vitagreen.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Healthy volunteer; Sublingual or oral aspirin 80mg tablet, single dose, two-treatment, two-period, two-sequence, randomized, crossover design, with washout 1-2 weeks	Drug: Sublingual aspirin; Vita Green Health Products sublingual aspirin 80 mg tablet; Drug: Oral aspirin; Synco (HK) oral aspirin 80mg tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak plasma concentration of salicylic acid	Peak plasma concentration for sublingual versus oral aspirin 80mg	pre dose and up to 24 hour post dose
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
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
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
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
Platelet aggregation by impedance aggregometry	Differences in platelet aggregation with sublingual versus oral aspirin 80mg	pre dose and up to 360 minutes post dose

Collaborators and Investigators

• Sponsor: Vita Green Health Products Co. Ltd

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 5, 2021
• Primary Completion (ANTICIPATED): July 1, 2021
• Study Completion (ANTICIPATED): September 1, 2021

Study Registration Dates

• First Submitted: March 4, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (ACTUAL): March 11, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 4, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: VG-BABE-19-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No