None listed
Conditions
Interventions
Drug : randomiation, open, 3x3 cross-over
1. Active conparator: ANPLAG® Immediate Release Tablet, 100mg tid a day
2. Experiment arm(fasted): Sarpogrelate hydrochloride 300mg Sustained Release Tablet,
Sponsors
Kunwha Pharmaceutical
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Healthy male 2.Between the ages of 20 and 45 years 3.weight; At least 55 kg and within 20% of Ideal Body Weight (IBW) 4.All subjects should be judged normal and healthy during a pre-study medical evaluation and test 5.The subject is willing to participate in this study as documented by written informed consent.
Exclusion criteria
Exclusion criteria: 1.Allergy or hypersensitivity to Sarpogrelate hydrochloride or any other related products. 2.History of any significant sickness; cardiovascular , hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic or neurologic disease, especially bleeding illness 3.History of any gastrointestinal disease which could affect the drug absorption 4.dignosis or suspenseful history of peptic ulcer within 60 days prior to the initial dose of study medication 5.Abnormal and clinically significant laboratory test results - ALT,AST >1.25 times than normal range - PT, aPTT, BT; over the normal range - Total bilirubin >1.25 times than normal range - Platelet count 350,000 6. SBP = 150 mmHg or = 90 mmHg, OR DBP = 95 mmHg or = 60 mmHg 7. History of drug and/or alcohol abuse or A positive test for any drug included in the urine drug screen. 8. Subjects participated in another clinical trial within 90 days prior to the initial dose of study medication. 9. Use of Barbiturate drug which could affect the drug metabolize enzyme within four weeks prior to the initial dose of study medication 10. Use of any prescription containing antiplatelet agent, anticoagulant and clotbuster within two weeks prior to the initial dose of study medication or over-the-counter (OTC) medications or vitamins within one week prior to the initial dose of study medication 11. A diet which could affect the drug absorption , metabolize and elimination 12. Use of whole blood 8 weeks and component Blood 4 week prior to the initial dose of study medication. 13. Over 10 tobaccos a day 14. A positive HIV, hepatitis B, or hepatitis C test. 15. The subject has any other clinically significant medical or psychiatric condition that in the opinion of the Investigator could impact the subject's ability to successfully complete this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax,AUCt of Sarpogrelate and M1 in Plasma concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax, t1/2, Vz/F, CL/F of Sarpogrelate and M1 in Plasma concentration | — |
Countries
Korea, Republic of
Contacts
Public Contactkim hee
Kunwha Pharmaceutical
Outcome results
None listed