JPRN-UMIN000016626已完成1 期
Clinical pharmacokinetic study of NIG-0392 on healthy adults. - Clinical pharmacokinetic study of NIG-0392 on healthy adults.
ichi-Iko Pharmaceutical Co., Ltd.0 个研究点目标入组 48 人开始时间: 2015年2月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
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
- 20years-old 至 40years-old（—）
- 性别
- Male
入选标准
- 未提供
排除标准
- •1)History of hypersensitivity for any elements involved in all the investigational agents in this study 2)Tuberculosis patient 3)Hyperthyroid patient 4)Hypothyroid patient 5)Renal dysfunction 6)Myotonia congenita 7)Hyperkalemia 8)Subjects who have history of hypocomplementemic urticarial vasculitis 9)Subjects who have history of hypersensitivity for iodine contrast agent 10)Subjects who have history of dermatitis herpetiformis Duhring 11)Subjects who take upper gastrointestinal endoscopy in the term from screening test to one week after administration. 12)Serological reaction of syphilis, HBsAg, HCVAb or HIVAb positive 13)AST(GOT) or ALT(GPT): more than the reference value by screening or clinical assay before the administration in each term(excluding the case of AST or ALT value within the standard value by reexamination) 14)Subjects who have present or past history of cardiovascular system, immune system, hematologic, brain vasculature, respiratory system, digestive system, liver or renal disease 15)History of gastrointestinal tract surgery which has an effect on the drug absorption such as gastrectomy, gastrointestinal suture, or intestinal resection 16)Presence of alcohol or drug dependency 17)Subjects who need some cure for actual allergic symptom, such as asthma, pollinosis, or atopic dermatitis 18)Subjects who use other medicine in the week prior to hospitalization of 1st period or need to take other medicine during the test (including external preparation etc.) 19)Enrolled in another investigational study and took other investigational drug within 4 months(if it is a patch test, within one month) 20)Subjects who donated and/or withdrawn whole blood more than 400mL within 12 weeks, 200mL within 4 weeks, and/or blood content within 2 weeks prior to the time of consent. 21)Subjects who are judged ineligible for entry to this study by the study physician
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