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Pharmacokinetic and Pharmacodynamic Study of a Novel Sublingual Aspirin Tablet

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ClinicalTrials.gov Identifier: NCT04792723
Recruitment Status : Not yet recruiting
First Posted : March 11, 2021
Last Update Posted : March 11, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Elaine Chow, Chinese University of Hong Kong

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Drug: Sublingual aspirin Drug: Oral aspirin Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: single-dose, two-treatment, two-period, two-sequence, randomized, crossover design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic and Pharmacodynamic Study of a Novel Sublingual Aspirin Tablet Compared to Conventional Oral Aspirin in Healthy Subjects
Estimated Study Start Date : March 5, 2021
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Plasma-concentration time data of salicylic acid [ Time Frame: pre dose and up to 24 hour post dose ]
    area under the plasma concentration-time curve from time zero to last measurable concentration time point for sublingual versus oral aspirin 80mg


Secondary Outcome Measures :
  1. Peak plasma concentration of salicylic acid [ Time Frame: pre dose and up to 24 hour post dose ]
    Peak plasma concentration for sublingual versus oral aspirin 80mg

  2. Time to reach peak plasma concentration of salicylic acid [ Time Frame: pre dose and up to 24 hour post dose ]
    Tmax of sublingual versus oral aspirin 80mg

  3. Terminal phase elimination rate constant of salicylic acid [ Time Frame: pre dose and up to 24 hour post dose ]
    Terminal phase elimination rate constant of sublingual versus oral aspirin 80mg

  4. Terminal elimination half-life of salicylic acid [ Time Frame: pre dose and up to 24 hour post dose ]
    Terminal elimination half-life of sublingual versus oral aspirin 80mg

  5. Plasma concentration time data of thromboxane B2 [ Time Frame: pre dose and up to 24 hour post dose ]
    Area under the curve for sublingual versus oral aspirin 80mg

  6. Platelet aggregation by impedance aggregometry [ Time Frame: pre dose and up to 360 minutes post dose ]
    Differences in platelet aggregation with sublingual versus oral aspirin 80mg


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04792723


Contacts
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Contact: Rolley Lee +852 29035983 rolley.lee@vitagreen.com

Sponsors and Collaborators
Vita Green Health Products Co. Ltd
Investigators
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Principal Investigator: Elaine Chow Chinese University of Hong Kong
More Information
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Responsible Party: Dr. Elaine Chow, Clinical Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04792723    
Other Study ID Numbers: VG-BABE-19-01
First Posted: March 11, 2021    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
 Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics