KCT0001767进行中（未招募）未知
A randomized, open-label, single-dose, 2-way cross-over study to compare the safety and the pharmacokinetic characteristics of CPBI402 in healthy male volunteers
Corepharmbio0 个研究点目标入组 34 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 34
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. Healthy male volunteers aged between 19 to 55 years at the time of screening.
- •2. Individuals with body weight more than 55 kg and Body Mass Index (BMI) between 18 and 27.
- •3. Individuals without congenital or chronic diseases and showing no symptoms of disease upon pathological examination.
- •4. Individuals who are judged fit and appropriate as the subjects based on reports of serology test, hematology test, blood chemistry test and clinical laboratory tests such as urinalysis and ECG results examined within 4 weeks before the first dose administration.
- •5. Individuals who can understand and follow the instructions and can participate before the start of clinical trial.
- •6. Individuals who have decided to participate in the clinical trial study on their own will and have signed the written consent to comply with the precautions after hearing and fully understanding the detailed explanations regarding the clinical trial study.
排除标准
- •1.Medical history
- •1)Individuals with clinically significant biliary tract diseases (biliary obstructive disorder etc.), renal diseases (severe renal failure etc.), urinary system diseases (Ischuria symptoms etc.), ophthalmic diseases (narrow angle glaucoma etc.), blood tumor, cardiovascular disease (congestive heart failure, arrhythmias, a complication of coronary artery stenosis, etc.), respiratory disease, liver disease (moderate or severe hepatic insufficiency, etc.), endocrine disorders (hypothyroidism, diabetes or impaired glucose tolerance, etc.), digestive disorders (toxic megacolon, etc.), musculoskeletal diseases (myopathy, myasthenia gravis, etc.), central nervous system disorders, mental illness or malignant tumor or having history of malignant tumor.
- •2)Individuals having gastrointestinal disease that can affect the absorption of drugs (Crohn’s disease, ulcers, gastritis, stomach cramps, gastroesophageal reflux, acute or chronic pancreatitis, etc.) or having a history of gastrointestinal surgery (however, simple appendectomy or hernia surgery, endoscopic submucosal resection, endoscopic polypectomy are excluded).
- •3)Individuals who have hypersensitivity or have history of clinically significant hypersensitivity reactions to the active ingredient or its analogous compounds of the drugs like benzoimidazoles, penicillin antibiotics, cephem antibiotics, macrolide antibiotics or other medicines (aspirin, antibiotics, etc.). (Conditions not requiring treatment with drug administration such as mild allergic rhinitis are excluded).
- •4)Individuals with atrial fibrillation and QT prolongation or ventricular arrhythmias (including Torsades de pointes)
- •5)Individuals who have suffered from any clinically significant disease within 30 days prior to the administration of first dose of clinical trial drug.
- •2. Clinical examination
- •1)After achieving sufficient stability in a sitting posture, the individuals having vital sign readings for systolic blood pressure above 150 mmHg or below 100 mmHg, or diastolic blood pressure reading above 100 mmHg or below 65 mmHg, or the measured pulse rate per minute above 100 or below 40.
- •2)Individuals with positive results in serological examination (hepatitis B and C, HIV test).
- •3)Active liver disease patient with persistent unexplained increase in hepatic microsomal enzymes (AST, ALT) or those patients with enzyme levels more than three times the normal limit.
- •4)Patients with kidney failure above severe renal impairment (GFR(glomerular filtration rate) & lt: 60 mL/min calculated according to Cockcroft- Gault law.
- •5)ECG examination result showing clinically significant findings, associated physical abnormality or presence of symptoms.
- •6)Experiment continuation deemed difficult by investigators when other physical examinations are carried out.
- •3. Allergy and drug abuse
- •1)Individuals having intolerance or genetic problems with the additives of CPBI402 (for example, Yellow no. 5).
- •2)Individuals showing positive results for drugs abuse in drug screening tests, or having history of drug abuse.
- •3)Individuals with genetic problems such as galactose intolerance, Lapp Lactase Deficiency or glucose-galactose malabsorption.
- •4.Prohibited combination drug / diet
- •1)Individuals who have taken test drugs from other clinical tests or bioequivalence tests within 90 days prior to the administration of test drug.
- •2)Individuals who have taken Korean traditional medicine within 28 days prior to test drug administration, or who
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