Clinical Trials to Compare the Pharmacokinetic Profiles of Sarpogrelate hydrochloride 300mg SR Tablet and ANPLAG® IR After Multiple Oral Administration to Healthy Male Subjects
- Conditions
- Not Applicable
- Registration Number
- KCT0000156
- Lead Sponsor
- Kunwha Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 18
1.Healthy male
2.Between the ages of 20 and 45 years
3.weight; At least 60 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.
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 <150,000 or > 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 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 or component Blood four weeks 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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax,ss, of Sarpogrelate and M1 in Plasma concentration ; AUC0-24h,ss of Sarpogrelate and M1 in Plasma concentration
- Secondary Outcome Measures
Name Time Method Tmax, of Sarpogrelate and M1 in Plasma concentration ;T1/2 of Sarpogrelate and M1 in Plasma concentration ; Vz/F of Sarpogrelate and M1 in Plasma concentration ; CL/F of Sarpogrelate and M1 in Plasma concentration ;Cmin,ss of Sarpogrelate and M1 in Plasma concentration ;Cave,ss, of Sarpogrelate and M1 in Plasma concentration ;degree of fluctuation [(Cmax,ss - Cmin,ss)/ Cave,ss] of Sarpogrelate and M1 in Plasma concentration ;swing [(Cmax,ss - Cmin,ss)/ Cmin,ss] of Sarpogrelate and M1 in Plasma concentration ;R(???? ? ???) of Sarpogrelate and M1 in Plasma concentration