KCT0004878尚未招募未知
A Clinical Trial for Evaluation of Pharmacokinetic interaction between WS1313D and NAC after Co-administration in Healthy Male Adult Subjects
Woosung Pharma0 个研究点目标入组 27 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
- 27
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 45(Year)（—）
- 性别
- All
入选标准
- •Subjects enrolled in this study must meet all of the following selection criteria:
- •1)Healthy adult males between 19 and 45 years old at the time of screening
- •2)A person who weighs more than 50kg and has a weight within ± 20% of the ideal body weight
- •3) A person who voluntarily decides to participate in a clinical trial and agrees to follow precautions after hearing a detailed description of the trial
排除标准
- •Subjects enrolled in this study are excluded if any of the following exclusion criteria apply.
- •1)Person who is unable to collect blood up to 7ml / kg per day as required by this study
- •2) Drugs containing acetaminophen (paracetamol) or propacetamol within 24 hours prior to clinical trial drug administration and within 12 hours prior to screening, or drugs containing probenecid, isoniazide within 48 hours And if you received medication containing disulfiram within a month
- •3) Patients with severe hepatic impairment or total bilirubin measured more than 1.5 times the normal upper limit of the clinical laboratory or whose ALT or AST is 2.5 times higher than the normal upper limit
- •4) Patients with severe renal impairment or those with an estimated glomerular filtration rate (eGFR) of 1/3 or less of the normal lower limit of the clinical laboratory
- •5) Patients with symptoms suspected of acute disease 28 days before the start of trial (clinical administration)
- •6) Patient Who has History that can affect the absorption, distribution, metabolism, and excretion of drugs(Cardiovascular system, respiratory system, kidney, endocrine system, hematology, digestive system, central nervous system, mental illness, or malignant tumor.)
- •7) Applicants deemed unsuitable as subjects through Health examination conducted within 28 days of start of trial (Screening items such as paperweight, blood pressure, 12-lead ECG, physical examination, blood, urine test)
- •8) Patients with Bilateral renal artery stenosis, renal artery stenosis in a single kidney, or only one side of the kidneys functioning, such as those who show abnormalities in renal function in the past
- •9) Patients with Clinically significant allergic disease(Excluding mild allergic rhinitis that does not require medication)
- •10) Those who have a history of hypersensitivity to drugs(Acetaminophen or NAC)
- •11) Participants in other clinical studies(Clinical Drug Administration) within 60 days of trial
- •12) Patient who took a specialty medication within 14 days of the start of the trial or a generic drug within 7 days of the start of the trial so that the investigator's judgment that the taking medication affects the test or the safety of the subject
- •13) Those who have had an abnormal meal that may affect the absorption, distribution, metabolism and excretion of the drug
- •14) Patient who has symptomatic systolic / diastolic blood pressure less than 110/60 mmHg in supine position(E.g. dizziness)
- •15) Patient who is unable to eat standard meals provided by the clinical institution
- •16) Those who donated whole blood within 60 days after the test or donated component blood donations within 30 days
- •17) People who continue to drink caffeine(Caffeine> 5 cups / day) or are unable to drink(Alcohol> 30g / day) during the clinical trial or are excessive smokers (Tobacco> 10 cigarettes / day)
- •18) A person who has judged that it is inappropriate according to the tester's judgment for other reasons.
- •19) Patient with aspirin asthma (induced asthma attack by nonsteroidal anti-inflammatory (anti-inflammatory)) or history of it
- •20) Those who have taken drug metabolism inducing and inhibitory drugs such as barbital drugs within 1 month before starting the test
研究者
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