KCT0004252已完成未知
A phase I clinical trial to investigate the food effect on the pharmacokinetics of NVP-1402 in healthy volunteers
avipharm0 个研究点目标入组 32 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
- 32
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 o Limit（—）
- 性别
- All
入选标准
- •1)Healthy adult male volunteers aged 19years old at screening
- •2)Body weight ? 50 kg within the range of 18.5~27.0 kg/m2 of the calculated BMI
- •?BMI = {weight(kg)/height(m)2
- •3)Without any congenital or chronic diseases requiring treatment, any pathological symptoms, or any abnormal findings on medical examination
- •4)Subjects evaluated eligible for the study based on the screening test results such as laboratory tests including serology, hematology, blood chemistry, and urinalysis, etc. and electrocardiogram(ECG).
- •5)Subjects who signed on the written informed consent form and comply with study requirements after listening and fully understanding the details of this study.
排除标准
- •1) Subjects with hypersensitivity to the active ingredients or other components of the investigational product(s) or medical history of significant hypersensitivity to other drugs or any additive(s).
- •2) Subjects with medical history to affect absorption, distribution, metabolism and elimination of drug(s) (disease(s) of hepatic/biliary, renal, cardiovascular, endocrine (hypothyroidism etc.), respiratory, digestive, hematologic, central nervous, psychiatric, musculoskeletal systems, etc.)
- •3) Subjects with active liver disease or alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels >1.5 times the upper limit of the normal range
- •4) Subjects with creatinine clearance <80 mL/min (Creatinine clearance calculated by Cockcroft-Gault’s formula using serum creatinine).
- •5) Those who showed signs of systolic blood pressure> 150 mmHg or <90 mmHg, or diastolic blood pressure> 100 mmHg or <60 mmHg in vital signs measured at rest after 3 minutes or more resting
- •6) Subjects with serious harms, surgical procedures or suspected symptoms of acute disease(s) (severe infection, severe injury, etc.) within 4 weeks prior to the first administration.
- •7) Subjects who continued excessive drinking alcohol (>21 units/week, 1unit=10g=12.5 mL of pure alcohol) or could not abstain from alcohol since 3 days before the day to conduct the study or excessive smokers (> 10 cigarettes /day).
- •8) Ingesting any prescription drug(s) or herbal medicine(s) within 2 weeks prior to the first administration or any over-the-counter (OTC) drug(s) within 1 week, judged by the investigator to affect this study or the safety of the study subjects.
- •9) History of Substance abuse
- •10) Subjects who participated in any other study within 3 months prior to the first administration (the end of the previous study is determined as the last day of administration).
- •11) Subjects who donated whole blood or partial blood within 2 or 1 month, respectively, prior to the first administration.
- •12) Subjects on abnormal diets which might affect absorption, distribution, metabolism and elimination of drug(s) or taking foods which might affect drug metabolism
- •13) Those who can not eat grapefruit (grapefruit) / caffeine-containing foods within the first 48 hours of administration
- •14) Someone who can't take a meal derived from this trial
- •15) Women who are pregnant or who may be pregnant and women who are lactating. Women who do not consent to appropriate contraception during the trial. (Postmenopausal women should be at least 12 months of amenorrhea to be considered non-fertile.)
- •16) Subjects judged not eligible for this study by principal investigator or subinvestigator (physician in charge).
研究者
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