KCT0000156招募中未知
Clinical Trials to Compare the Pharmacokinetic Profiles of Sarpogrelate hydrochloride 300mg Sustained Release Tablet and ANPLAG® Immediate Release Tablet After Multiple Oral Administration to Healthy Male Subjects
Kunwha Pharmaceutical0 个研究点目标入组 18 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 45(Year)（—）
- 性别
- Male
入选标准
- •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.
排除标准
- •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.
研究者
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