KCT0001610尚未招募未知
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 Pharm0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
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 50(Year)（—）
- 性别
- Male
入选标准
- •1.Healthy male volunteer, age 19~50 years
- •2.Weight =55kg and =90kg, The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
- •3.Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
- •4.Subjects who judged ineligible by the investigator.
排除标准
- •1.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.
- •2.Presence of medical history or a concurrent disease that may interfere with absorption of drugs including clinically significant disorders in GI tract
- •3.History of relevant drug allergies(i.e Tamsulosin, other Alpha blocker, Aspirin, Antibiotics etc) or clinically significant hypersesnsitivity reaction.
- •4.History of relevant food allergies(i.e. peanut,milk) or clinically significant hypersensitivity reaction.
研究者
相似试验
进行中（未招募）
1 期
A single-dose, open-label, randomised, three-way crossover study to assess the comparative bioavailability of Captopril oral solution 5 mg/mL relative to captopril tablets and to investigate the effect of food on the pharmacokinetics of Captopril oral solution in healthy adult volunteersCaptopril 5 mg/mL oral solution is a new oral pharmaceutical formulation intended for the treatment of congestive heart failure in male and female paediatric patients from birth to 18 years.EUCTR2019-000258-76-ESProveca Ltd.24
已完成
不适用
A single-dose, open label, randomized, three-way cross-over study in healthy volunteers to characterize the pharmacokinetics of the 300 mg trientine capsule and to assess the effect of dissolution rate and the effect of food on the pharmacokinetics of trientine.NL-OMON46237nivar BV24
已完成
不适用
Relative bioavailability study of two candidate tablet formulations of 16mg candesartan cilexetil (GW615775) compared with the reference product Atacand (16mg candesartan cilexetil, AstraZeneca) in healthy human subjects under fasting conditionsCTRI/2014/12/005269GlaxoSmithKline Research and Development Limited18
已完成
不适用
Relative bioavailability of clopidogrel 75mg from two tablet formulations of SB224326 relative to one 75mg reference tablet of clopidogrel in healthy adult human subjects under fasting conditionsCTRI/2016/04/006789GlaxoSmithKline Research and Development Limited18
进行中（未招募）
不适用
Clinical study to test that the drug CHF 1535 100/6 (fixed combination of an anti-inflammatory drug and relaxing airways drug) delivered via pressurized inhaler using or not a spacer device is as effective in adolescent population as the licensed free combination of the same substances and compare it with administration in adults.MedDRA version: 14.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersAsthmaEUCTR2011-005108-14-PLChiesi Farmaceutici S.p.A.