KCT0001311已完成未知
A randomized, open, single-dose, 3-treatment, 3-period, 6-sequence crossover study in healthy male subjects to evaluate the pharmacokinetics of GLA5PR GLARS-NF1 tablet 150mg and LYRICA® capsule 75mg
GL PharmTech0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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 45(Year)（—）
- 性别
- Male
入选标准
- •(1) 20~ 45 aged healthy adult male
- •(2) Body weight at least 45kg and BMI(body mass index) within the range of 17.5 to 30.5kg/m2
- •(3) Do not have any disease or symptoms which is clinically significant
- •(4) Acceptable physical examination and clinical examination, during screening
- •(5) Provision of signed written informed consent
排除标准
- •(1) Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
- •(2) Any condition possibly affecting drug absorption (eg, gastrectomy)
- •(3) someone who has taken alcohol more than 30g/day
- •(4) Participation in clinical trials of any drug within 60 days prior to the participation of the study
- •(5) Systolic BP =140 mmHg or Diastolic BP =90 mmHg
- •(6) someone who has a history of drug abuse or misuse
- •(7) IP first dose before significant induction or that person taking drugs known to inhibit drug-metabolizing enzymes within 30 days
- •(8) Use of tobacco in excess of the equivalent of 5 cigarettes per day
- •(9) someone who has taken other ETC drugs or OTC drugs within the last 10 days or 5 half lives(whichever is longer)
- •(10) Blood donation during 2 months or apheresis during 1 month before the study
- •(11) Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol
- •(12) someone who can't take a meal derived from this trial
- •(13) someone who has taken abnormal meals like which can affect to drug ADME
- •(14) Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
- •(15) Allergy or intolerance to one of the study medications
- •(16) someone who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •(17) Judged to be inappropriate for the study by the investigator after reviewing other reasons
研究者
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