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临床试验/NCT01830309
NCT01830309已完成1 期

Clinical Study to Evaluate Food-Effect on Pharmacokinetics and Pharmacodynamics of Single Oral Dose of CJ-12420 in Healthy Male Subjects

HK inno.N Corporation1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
24
试验地点
1
主要终点
Geometric mean ratio and 90% CI for log-transformed AUClast

研究概览

简要总结

  • Primary: To evaluate food effect on the pharmacokinetics (PK) of a single oral dose of CJ-12420 in healthy male subjects.

  • Secondary

  • To explore food effect on the pharmacodynamics (PD) of single oral dose of CJ-12420 in healthy male subjects(PD/PK group)

  • To evaluate the safety of single oral dose of CJ-12420 in healthy male subjects under fed or fasting condition.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Male volunteers in the age between 20 and 45 years old(inclusive)
  • Body mass index (BMI) in the range of 19 to 28 kg/m2 and weighing at least 50 kg (inclusive)
  • Medically healthy with no clinically significant vital signs (sitting position blood pressure, pulse rate)
  • 90 mmHg ≤ systolic blood pressure ≤ 140 mmHg
  • 50 mmHg ≤ diastolic blood pressure ≤ 95 mmHg
  • 45 beats per minute ≤ pulse rate ≤ 95 beats per minute
  • Understand the requirements of the study and voluntarily consent to participate in the study

排除标准

  • Subjects will be excluded from the study if there is evidence of any of the following criteria: Last three criteria will be applied ONLY to PD/PK group.
  • History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary,immunologic, psychiatric, musculoskeletal or cardiovascular disease or any other condition, which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results
  • History of allergy or sensitivity to any drug, including any prior serious adverse reaction to PPIs (e.g. omeprazole, rabeprazole, lansoprazole)
  • History of symptomatic GERD, erosive esophagitis, duodenal ulcer, gastric ulcer, Barrett's esophagus or Zollinger-Ellison syndrome, previous positive H. pylori
  • The following criteria will be applied ONLY to PD/PK group
  • H.pylori positive, as determined by the urea breath test
  • Urine cotinine test positive
  • Subject who were unable to be applicable for pH meter catheter

研究组 & 干预措施

Sequence 1

Experimental

Drug: CJ-12420 200mg Period1: CJ-12420 under fed condition Period2: CJ-12420 under fasting condition

干预措施: CJ-12420 200mg (Drug)

Sequence 2

Experimental

Drug: CJ-12420 200mg Period1: CJ-12420 under fasting condition Period2: CJ-12420 under fed condition

干预措施: CJ-12420 200mg (Drug)

结局指标

主要结局

Geometric mean ratio and 90% CI for log-transformed AUClast

时间窗: Blood sampling during 24 or 48 hrs after administration

Geometric mean ratio and 90% CI for log-transformed Cmax

时间窗: Blood sampling during 24 or 48 hrs after administration

次要结局

  • time pH > 4(24 hour before and after IP administration)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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