KCT0009163已完成Unknown
Phase 1 study to evaluate the pharmacokinetics and the safety of KDF2001 in healthy adult volunteers
Kyung Dong Pharmaceutical0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) 19 years old or older at screening visit
- •2) weighed 50 kg or more (45 kg or more for female) with body-mass index of 18 to 30 kg/m^2 at screening visit
- •3) neither clinically significant congenital or chronic diseases, nor pathologic symptoms or findings in medical examinations at screening visit
- •4) eligible in laboratory tests and electrocardiogram
- •5) proper contraception for volunteer and his/her partners, restrictions of sperm or egg donation throughout the study
- •6) voluntary sign on informed consent form after fully understating the study.
排除标准
- •1) clinically significant gastrointestinal, cardiovascular, endocrine, respiratory, hematologic, oncologic, infectious, nephrologic, urologic, psychologic, musculoskeletal, immunologic, otolaryngologic, dermatologic, or ophthalmologic diseases or history.
- •2) gastrointestinal surgery or disease affecting absorption of oral medications
- •3) drug metabolism inducers or inhibitors within 1 month, or clinical trial-interfering medications within 10 days
- •4) other investigational products withing 6 months
- •5) whole blood donation within 8 weeks, apheresis within 2 weeks, or blood transfusion within 4 weeks
- •6) following conditions within 1 month
- •6-1) alcohol consumption over 21 drinks per week for male, over 14 drinks per female
- •6-2) smoking over 20 cigarettes a day
- •7) following conditions
- •7-1) hypersensitivity to active ingredients or excipients of investigational products
- •7-2) galactose intolerance, Lapp lactase deficienty, or glucose-galactose malabsorption
- •8) following diseases
- •8-1) type 1 diabetes mellitus or diabetic ketoacidosis
- •8-2) glomerular filtration rate under 60 mL/min/1.73 m^2
- •8-2) end stage renal disease or dialysis
- •9) ineligible at the discretion of principal investigator due to reasons other than above criteria
- •10) pregnant or breast-feeding female
研究者
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