KCT0001376已完成未知
A Randomized, open-label, multiple-dose, crossover phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of Losartan after oral administration in healthy male volunteer
Dong Hwa Pharm0 个研究点目标入组 12 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 12
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 55(Year)（—）
- 性别
- Male
入选标准
- •1) A healthy male adult within the range of 19 to 55 years old at the time of screening
- •2) BMI=17.5~30.5kg/m2, one with weight of more than 45kg (BMI= kg/(m)2)
- •3) Congenital or chronic diseases within the last three years, there is no medical examination results of popular characters with no psychotic symptoms or findings
- •4) Doctor checks conducted hematology, blood chemistry, urinalysis and laboratory tests, including an EKG performed during screening tests such as a suitable test subjects who judged
- •5)The purpose of the test participants prior to testing, information, and to hear about the free will fully explain to participate in this study, according to the Chonbuk National University Hospital IRB-approved consent form signed by the parties in writing
排除标准
- •(1) one with clinically significant blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic disease (but ,except for untreated seasonal allergies of asymptomatic at the time of administration) with medical history or evidence
- •(2) one with gastrointestinal disease(Such as esophageal stricture or achalasia of the esophagus disease, Crohn disease) to affect drug absorption or surgery(but, excluding simple appendectomy or hernia surgery) with medical history
- •(3) ALT(alanine aminotransferase) or AST(aspartate aminotransferase) > 2 times the upper limit of the normal range
- •(4) Within 6 months, 210 g / week of alcohol in excess of a history of regular characters (beer (5%) 1 cup (250 mL) = 10 g, soju(20%) 1 cup (50 mL) = 8 g, Wine (12%) 1 cup (125 mL) = 12 g)
- •(5) Take part in other clinical trials within two months
- •(6) SBP(systolic blood pressure) = 140 mmHg or DBP(diastolic blood pressure) = 90 mmHg
- •(7) The great history of alcohol or drug abuse within 1 year
- •(8) Taking medication of drug-metabolizing enzymes that are known to significantly induce or inhibit within 30 days
- •(9) More than 20 cigarettes a day smoker
- •(10) Taking medication of a prescription drug or nonprescription within 10 days,
- •(11) One who whole blood donation in two months or apheresis donation in one month before administraing the first Investigational product
- •(12) One who may be at increased risk or may interfere test results with severe acute/ chronic medical, mental condition or abnomal result of laboratory test due to participate in clinical trials and administrate of investigational product
- •(13) Patient with hypersensitivity to investigational products or ingredients
- •(14) Patients with hereditary angioedema or angioedema
- •(15) Patients with aldosteronism
- •(16) galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- •(17) Aliskiren-containing medicine (GFR(glomerular filtration rate) <60mL/min/1.73?)
- •(18) One who is not interested in compliance or can not comply with described lifestyle in this protocol
- •(19) One who is unfit to participate in clinical trials, the invesigator make a decision
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