KCT0000983已完成未知
Clinical trial to investigate the extent of P-glycoprotein inhibition after oral administration of HM30181A in healthy male subjects: An open, single sequence, 4-period crossover within dose group, parallel dose group design
Hanmi Pharm0 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
- 已完成
- 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 50(Year)（—）
- 性别
- Male
入选标准
- •1) healthy male at the age of 20-50
- •2) body weight >=50kg and within 20% of ideal body weight
排除标准
- •1) Clinically significant past history in liver, kidney, psychiatry, pulmonary, endocrinology, blood, tumor, circulation system
- •2) Gastrointestinal disease(e.g. Crohn's sease) which can influence on the absorption of investigational product
- •3) Opthalmological disease which can influence on the opthalmic exam.
- •4) Alanine aminotransferase(ALT),alanin aminotransferase(ALT) > 1.25 times of upper normal limit
- •5) Systolic blood pressure < 100 mmHg or > 150 mmHg, or diastolic blood pressure < 65 mmHg or > 95 mmHg
- •6) QTc >450 msec or clinically significant abnormal finding in electrocardiography
- •7) Drug hypersensitivity history
- •8) Drug abuse history or positive finding in urine drug screening
- •9) Administration of priscribing drug or herbal drug within 2 weeks of IP administration, or administration of over the count(OTC) drug or vitamin within 1 weeks of investigational drug administration
- •10) Participation in other trial within 2 months of investigational administration
- •11) Whole blood donation within 2 months or component donation within 2 weeks of investigational administration
- •12) Excessive drinking(>21 units/week) or subject who cannot stop drinking during trial
- •13) Smoker (ex-smoker who stops smoking 3months before investigational administration can participate)
- •14) Subject who consumed food containing caffein or grapefruite or drank alcohol during prohibited period
- •15) Subject who was judged not eligible due to laboratory results and etc. by investigator
研究者
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