KCT0004055尚未招募未知
Pharmacokinetics Research Phase I Phase 1 Researcher Clinical Trials (Palmultang soft extract)
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 15
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
- 20(Year) 至 55(Year)（—）
- 性别
- Male
入选标准
- •1)Healthy male Korean subject age 20 to 55 at the screening visit
- •2)Subject who is over 55kg and As a result of calculated Ideal Body Weight, subject who is within the range of ±20%
- •* IBW (kg) = {height(cm) - 100} * 0.9
- •3)Physical examination was performed on the basis of this protocol, a subject who has been determined to be suitable to the subject of clinical trials via the interview. That is, subject who does not have congenital or chronic disease and as a result of medical examination(if necessary,EEG,chest and upper gastrointestinal endoscopy or radiography), subject who is no pathological symptoms or findings
- •4)A person who is determined to be eligible for clinical trial as a result of a clinical pathology test, such as blood pathology test, blood chemistry test, urine test, etc.,
- •5)After understanding to hear detaily description of the clinical trial, subject who decided voluntarily to participate in clinical trail and agreed to observe notice
- •6)Patients with a previous history of hypertension, no history of antihypertensive medication, and those with a systolic blood pressure <140 mmHg and a diastolic blood pressure <90 mmHg in vital signs measured from the left after a rest of more than 3 minutes as measured in the main body
排除标准
- •1)A person who has taken liver, kidneys, nervous system, immune system, respiratory, musculoskeletal disease or blood available and the endocrine system and cancer diseases, cardiovascular diseases, mental disorders (mood disorders, obsessive compulsive disorder, etc.) who have a history or are(In the case of liver disease item, or hepatitis B antigen, including one who shows a hepatitis C antibody positive).
- •In particular,A person who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- •2)A person who has taken gastrointestinal diseases (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) and a history of gastrointestinal surgery (where the simple appendectomy or hernia operation is excluded)
- •3)A person who had some lab data below.
- •After the break in the sitting position measured vital signs,systolic blood pressure = 140mmHg or diastolic blood pressure =90mmHg
- •4)A person who has taken alcohol more than 30g/day or someone who can't stop drinking from 24hours before enrollment to discharging from hospital.
- •5)A person who has taken xanthine continuously (coffee, tea, cola more than 4 cups per a day)
- •6)A person who smoked more than 20 piece of tobacco/day or can't stop smoking from on the day of blood collection period
- •7))A person who had enrolled to barbiturate's drugs by induction and inhibition of drug-metabolizing enzymes of drugs, such as drugs or excessive drinking within the last 30 days.
- •8)A person who has medical history of drug abuse or misuse (Amphetamine,barbiturates, cocaine, opioids, benzodiazepines, etc.)
- •9) A person who has taken other prescription medicine or oriental drugs within the last 30 days, or Over the Prescription drugs within the last 14 days ,or Over the generic drugs within the last 10 days
- •10)A person who had enrolled to participated in different bioequivalence studies or other clinical trial within the last 90 days.
- •11)A person who can't take a meal derived from this trial.
- •12)A person who is determined to be unsuitable about participation in clinical trial
- •13)Persons with severe renal dysfunction (SCr>2.0 mg/dL)
- •14)Persons with severe liver dysfunction(ALT, AST, alkaline phosphatase=2.5 times the normal upper limit)
- •15)Those who have hypersensitivity to the components of the clinical trial drug and similar drugs
- •A person who has received a whole blood donation within 2 months before the first administration date or a component blood donation within 1 month, or who received a blood transfusion within 1 month before the first administration day
研究者
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