Pharmacokinetic and Pharmacodynamic Study of a Novel Sublingual Aspirin Tablet

NCT04792723 | Unknown Phase 1

• 1 other identifier: VG-BABE-19-01
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Peak plasma concentration of salicylic acid

  pre dose and up to 24 hour post dose

• Time to reach peak plasma concentration of salicylic acid

  pre dose and up to 24 hour post dose

• Terminal phase elimination rate constant of salicylic acid

  pre dose and up to 24 hour post dose

• Terminal elimination half-life of salicylic acid

  pre dose and up to 24 hour post dose

• Plasma concentration time data of thromboxane B2

  pre dose and up to 24 hour post dose

Study Arms (1)

Healthy volunteer

EXPERIMENTAL

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; Drug: Oral aspirin

Interventions

Sublingual aspirin DRUG

Vita Green Health Products sublingual aspirin 80 mg tablet

Healthy volunteer

Oral aspirin DRUG

Synco (HK) oral aspirin 80mg tablet

Healthy volunteer

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male, 18 to 55 years of age
• Body mass index between 18-27kg/m2
• Accessible vein for blood sampling
• High probability for compliance and completion of the study
• No significant abnormalities in general physical examination
• 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

You may not qualify if:

• History of hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to screening
• Clinically relevant abnormality in physical examination, ECG evaluation, urine test, blood chemistry or haematological test at the discretion of the investigator
• Positive results for hepatitis B at screening
• Moderate smoker (on average more than 2 cigarettes a day within 1 month prior to the start of first dosing)
• Moderate consumption of alcohol (on average more than one drink per day within 1 month prior to start of first dosing)
• Blood donation of more than 350 ml within 4 weeks prior to start of first drug dosing
• Treatment of aspirin within 4 weeks before first dosing
• Volunteer in any other clinical drug study within 2 months prior to start of first dosing
• Hypersensitivity to aspirin or other drug in its class

Sponsors & Collaborators

• Vita Green Health Products Co. Ltd: lead

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Elaine Chow

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rolley Lee

CONTACT

+852 29035983; rolley.lee@vitagreen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: single-dose, two-treatment, two-period, two-sequence, randomized, crossover design

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 11, 2021
• Study Start: March 5, 2021
• Primary Completion: July 1, 2021
• Study Completion: September 1, 2021
• Last Updated: March 11, 2021

Record last verified: 2021-03