KCT0001829已完成未知
An integrative pharmacogenetic - pharmacometabolomic study to predict individualized pharmacokinetics of glimepiride in healthy Korean male subjects
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 16
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 55(Year)（—）
- 性别
- Male
入选标准
- •1) Healthy male subject aged =19 years at screening
- •2) Body weight of = 50 kg and within ± 20% of ideal body weight
- •? IBW (kg) = height (cm) - 100} * 0.9
- •3) Subject that is considered eligible for medical history and physical examination conducted in accordance with the study protocol, with no congenital or chronic disease
- •4) Subject that is considered eligible for participating in the study by an investigator, based on clinical laboratory test (serology, hematology, clinical chemistry, urinalysis, etc.) and ECG, prior to administration of study drug (results : normal or no clinical significant)
- •5) Subjects who understand a detailed explanation of the study protocol, voluntarily decide to participate and follow the study instructions, and sign Informed Consent
排除标准
- •1) Medical History of clinically significant hypersensitivity to Glimepiride, sulfonylurea, sulfonamide (major ingredient or any other ingredient)
- •2) congenital or chronic disease(endocrine disease(ex,Diabetes Mellitus), etc), pathological symptoms or findings of medical examination
- •3) History of gastrointestinal disease (e.g., Crohn’s disease, active peptic ulcer) or gastrointestinal surgery that may affect the absorption of the study drug (excluding simple appendectomy or herniorrhaphy)
- •4) History of major injury, surgical operation, or suspected symptom of acute illness within 4 weeks prior to the first administration of study drug
- •5) history of drug abuse
- •6) Use of any prescribed drugs or herbal remedies within 2 weeks, or use of any over-the-counter medication within 1 week prior to the first administration of study drug, and this will affect this study or the safety of the subjects in the opinion of the investigator
- •7) Participation in any other study within 3 months prior to the first administration of study drug (The completion date of previous study is the day of the last administration of study drug)
- •8) Donation of whole blood within 2 months prior to the first administration of study drug, or donation of any blood component within 1 month prior to the first administration of study drug
- •9) History of excessive alcohol abuse (>21 units/week, 1 unit=10g=12.5mL of pure alcohol), or subjects who cannot abstain from drinking during the study period
- •10)Abnormal diet that may affect absorption, distribution, metabolism and excretion of drugs (*e.g., Grapefruit juice = 1L /day within 7 days prior to administration of study drug)
- •11)Positive serologic tests (HBsAg, HCV Ab(Hepatitis C Virus anti-body), HIV Ag/Ab, VDRL(venereal disease research laboratory))
- •12)Evidence of hereditary disease, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •13)Subject that is not eligible to participate at the discretion of study investigator, based on clinical laboratory test (serology, hematology, clinical chemistry, urinalysis) or any other reason
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