Pharmacokinetic and Pharmacodynamic Study of a Novel Sublingual Aspirin Tablet

Vita Green Health Products

Status and phase: Unknown; Phase 1

Conditions: Cardiovascular Diseases

Treatments: Drug: Sublingual aspirin; Drug: Oral aspirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04792723

VG-BABE-19-01

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Healthy volunteer

Experimental group

Description:

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

Treatment:

Drug: Sublingual aspirin

Drug: Oral aspirin