Bioavailability and Pharmacodynamic study of Disgren EC capsule(Triflusal 300mg)

Not Applicable

Completed

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0001299
• Lead Sponsor: Kyungpook National University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 38

Inclusion Criteria

•Healthy male subjects between the ages of 20 and 55 years at screening;
•No abnormal symptom or sign, based on medical history and physical examination, with no congenital or chronic disease that requires treatment;
•Subject that is considered eligible for participating in the study by an investigator, based on clinical laboratory test (hematology, clinical chemistry, urinalysis, etc.);
•Hemorrhagic tendencies from medical history.

Exclusion Criteria

•Use of barbital drugs or alcohol abuse within 1 month prior to the study initiation;
•Use of drugs disrupting this study within 10 days prior to the study initiation;
•Medical history of clinically significant hypersensitivity to study drug;
•Subject that is not eligible to participate at this study, based on discretion of study investigator;
•Smoker;
•Clinical abnormalities at clinical laboratory test.
- The levels of aspartate aminotransferase (serum glutamic oxaloacetic transaminase) or alanine aminotransferase (serum glutamic pyruvic transaminase) > 1.25 x the upper limit of normal
- The levels of Total bilirubin > 1.25 x the upper limit of normal
- Platelet count(<180,000 or >350,000)
- prothrombin time (PT), activated partial thromboplastin time (aPTT) , and bleeding time (BT) > normal

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AUC(area under the concentration-time curve);Emax

Secondary Outcome Measures

Name	Time	Method
Tmax(the time of Cmax)