Pharmacokinetic and Pharmacodynamic Study of a Novel Sublingual Aspirin Tablet

Launched by VITA GREEN HEALTH PRODUCTS CO. LTD · Mar 4, 2021

Keywords

ClinConnect Summary

No description provided

Gender

MALE

Eligibility 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