KCT0001438进行中（未招募）未知
A randomized, open-label, multiple dosing, 3-way crossover study to evaluate the drug-drug interaction between Atorvastatin and Fenofibric acid in healthy male volunteers
Chong Kun Dang0 个研究点目标入组 30 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
- 30
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 o Limit（—）
- 性别
- Male
入选标准
- •1. Healthy man older than 19 years at the time of screening.
- •2. BMI more than 17.5kg / m2 and less than 30.5kg / m2 and weight more than 55kg
- •3. Subject without congenital or chronic diseases and no psychotic symptoms or findings from the medical examination.
- •4. Suitable subject who is determined by laboratory tests such as hematology tests, blood chemistry, urinalysis test according to the characteristics of the drug and screening tests such as ECG test.
- •5. Subject who fully understand the clinical trials after in-depth explanation given prior to the clinical study, decided to join the clinical trials by their will and signed consent form which approved by Chonbuk National University Hospital IRB.
- •6. Subjects who are able to comply with all scheduled visits, laboratory tests and other procedures.
排除标准
- •1. Subject who has a history of blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic diseases that is clinically significant (Except untreated asymptomatic seasonal allergies at the time of administration)
- •2. Subject who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption.
- •3. Showing the value that corresponds to following laboratory parameters: AST or AST or CK > 2* upper limit of normal range.
- •4. Alcohol > 210g/week, within 6 months prior to the screening.
- •5. Taking the medication involved in other clinical trials within two months before the first dose medication characters.
- •6. Sitting Systolic Blood Pressure = 140 mmHg, Diastolic Blood Pressure = 90 mmHg at the time of screening.
- •7. History of alcohol or drug abuse, within 1 year
- •8. Subjects who treated with metabolizing enzyme inducers or inhibitors such as barbitals within 30days prior to the first dosing.
- •9. Smoker (> 20cigarettes/day)
- •10. Subjects who takes ETC or OTC medicine within 10days before the first IP administration.
- •11. Subject who done the whole blood donation within two months or component blood donation within 1 month within 1 month prior to the first dosing.
- •12. Subject who can increase risk due to clinical test and administration of drugs or has Severe grade / chronic medical, mental condition or abnormal laboratory result that may interfere with the analysis of test results.
- •13. Subject with serious history of hypersensitivity or allergy to investigational product.
- •14. Active liver disease.
- •15. Muscle disease.
- •16. Subject with genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption.
- •17. Patients with severe hepatic impairment or Gallbladder Disease.
- •18. Patients with moderate to severe renal impairment.
- •19. Patients experienced allergy or phototoxicity during treatment with fibrate or ketoprofen.
- •20. Subjects who is not able to comply with guidelines described in the protocol.
- •21. Subjects who is determined by investigator's decision as unsuitable for clinical trial participation.
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