KCT0001635进行中（未招募）未知
A Randomized, Open, 2-way cross-over, Single dose study to Evaluate and Compare Safety and Pharmacokinetics of the HIP1302 and HGP1406 in Healthy Korean Male Volunteers
Hanmi Pharm0 个研究点目标入组 38 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 38
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
- 19(Year) 至 50(Year)（—）
- 性别
- Male
入选标准
- •1.Healthy male volunteer, age 19~50 years
- •2.Weight =55kg and =90kg, The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
- •3.Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
- •4.Subjects who judged ineligible by the investigator.
排除标准
- •1.Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in liver, kidney, nervous system, respiratory system, endocrine system,blood dyscracia, neoplasm,cardiovascular system,genitourinary system or psychiatric system.
- •2.Presence of medical history or a concurrent disease that may interfere with PK/PD evaluation of drugs including clinically significant disorders in Gastrointestinal tract
- •3.Subject who has genetic problems (i.e galactose intolerance, Lapp lactose deficiency and glucose-galactose malabsorption etc)
- •4.History of relevant drug allergies(i.e Tenofovir, Aspirin, Antibiotics etc) or clinically significant hypersesnsitivity reaction.
研究者
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