None listed
Conditions
Interventions
Drug : Triflusal capsule (Disgren capsule, 300 mg), as the reference formulation, and triflusal EC capsule (Disgren enteric-coated capsule, 300 mg), as the test formulation were manufactured and provi
Sponsors
Kyungpook National University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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(350,000) - prothrombin time (PT), activated partial thromboplastin time (aPTT) , and bleeding time (BT) > normal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC(area under the concentration-time curve);Emax | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax(the time of Cmax) | — |
Countries
Korea, Republic of
Contacts
Public ContactYoung-Ran Yoon
Kyungpook National University Hospital
Outcome results
None listed