A Randomized, Open-label, Single Dose, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetics Incorporating a Comparison of Fed/Fasted Pharmacokinetics of HIP1402 in Healthy Male Volunteers

Hanmi Pharmaceutical Company Limited0 个研究点目标入组 24 人开始时间: 2015年9月最近更新: 2016年10月13日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 24
主要终点: Tamsulosin, AUC(AUClast, AUCinf),

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

To investigate the PK charateristics and the effect of food on the PK in healthy male volunteers who receive HIP1402 capsule in fed versus fasted condition

详细描述

A randomized, open-label, single dose, three-way crossover clinical trial to investigate the pharmacokinetics incorporating a comparison of fed/fasted pharmacokinetics of HIP1402 in healthy male volunteers

研究设计

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

入排标准

年龄范围: 19 Years 至 50 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Healthy male volunteer, age 19~50 years
•Weight ≥55kg and ≤90kg, The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
•Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
•Subject who has the ability and willingness to participate the whole period of trial

排除标准

•Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
•History of relevant drug allergies or clinically significant hypersensitivity reaction.
•Systolic Blood Pressure: lower than 100mmHg or higher than 150mmHg, Diastolic Blood Pressure: lower than 60mmHg or higher than 100mmHg
•Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
•Subjects who took prescription drugs within 14 days from the patient screening or non-prescription medicine within 7 days which can affect the result of this clinical trial (acceptable according to the investigator's judgement)
•Intake of more than 210g of alcohol per week or who can't abstain from alcohol during the trial.
•Subjects who smoke more than 10 cigarettes per day or who can't quit smoking during the trial.
•Positive screening on Hepatitis B surface antigen(HBsAg), anti-Hepatitis C virus(HCV) or anti-Human immunodeficiency virus(HIV).
•Subjects who judged ineligible by the investigator.

研究组 & 干预措施

Sequence 1

Experimental

High fat diet+HGP0412 → High fat diet+HIP1402 → fasted state+HIP1402

干预措施: HIP1402 (Drug)

Sequence 1

Experimental

High fat diet+HGP0412 → High fat diet+HIP1402 → fasted state+HIP1402

干预措施: HGP0412 (Drug)

Sequence 2

Experimental

High fat diet+HIP1402 → fasted state+HIP1402 → High fat diet+HGP0412

干预措施: HIP1402 (Drug)

Sequence 2

Experimental

High fat diet+HIP1402 → fasted state+HIP1402 → High fat diet+HGP0412

干预措施: HGP0412 (Drug)

Sequence 3

Experimental

fasted state+HIP1402 → High fat diet+HGP0412 → High fat diet+HIP1402

干预措施: HIP1402 (Drug)

Sequence 3

Experimental

fasted state+HIP1402 → High fat diet+HGP0412 → High fat diet+HIP1402

干预措施: HGP0412 (Drug)