Status:
UNKNOWN
Pharmacokinetic and Pharmacodynamic Study of a Novel Sublingual Aspirin Tablet
Lead Sponsor:
Vita Green Health Products Co. Ltd
Conditions:
Cardiovascular Diseases
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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 fa...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04792723
Start Date
March 5 2021
End Date
September 1 2021
Last Update
March 11 2021
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