KCT0007827招募中未知
A open-label, multiple-dose, two-arm, one-sequence, crossover study to investigate the pharmacokinetic drug interaction between Pitavastatin and Ezetimibe after oral administration in healthy volunteers
Kuhnil Pharm.0 个研究点目标入组 56 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 56
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
- All
入选标准
- •1. A subject who is 19 years of age or older during screening
- •2. Obesity index BMI of 18.0 to 30.0
- •3, A subject who has no clinically significant congenital or chronic disease and has no pathological symptoms or findings as a result of medical examination
- •4, A subject who was selected by principal investigator as a result of a diagnostic test which conducted according to the characteristics of a clinical trial
- •5, A subject who signs the informed consent form after understanding sufficient explanation about the purpose and contents of this study, the characteristics of the IP, the expected adverse reactions, etc
- •6, A subject who agrees to exclude the possibility of pregnancy by himself or his or her spouse or partner using medically recognized contraception and does not provide sperm or ovum from the date of the first administration of the IP to the 14th day after the last administration of the IP
排除标准
- •1. A subject who has a clinically significant disease or history corresponding to the digestive system, cardiovascular, endocrine system, respiratory system, hematologic malignancy, infectious disease, kidney and genitourinary system, psychoneuro system, musculoskeletal system, immune system, otolaryngological system, skin system, and ophthalmology
- •2. A subject who has taken a drug metabolism-inducing or inhibiting drug such as a barbital drug within one month of the first administration or who has taken a drug that may interfere with this clinical trial within 10 days before the first administration
- •3. A subject who has participated in a clinical trial within 6 months before the first date of administration and has experience in administering a IP
- •4. A subject who donated whole blood within 8 weeks before the first administration or donated component blood within 2 weeks or received blood within 4 weeks
- •5. A subject who has a history of gastrointestinal surgery (excluding appendectomy or hernia surgery) that may affect the absorption of drugs or has gastrointestinal diseases
- •6. A Subject who has alchol abuse within one month before the first administration
- •7. Patient with the following diseases:
- •Patient with hypersensitivity or a medical history of hypersensitivity to the ingredients of IP
- •Patient with active liver disease or patients with continuous elevated levels of unconfirmed aminotransferase
- •Patient with severe liver failure or biliary obstruction and bile congestion
- •a cyclosporin-treated patient
- •a muscular dystrophy patient
- •Patient with severe liver dysfunction, gallbladder disease, and renal dysfunction
- •Patient with genetic problems such as galactose intolerance, Lapp lactase deficiency, and poor glucose-galactose absorption because the drug contains lactose
- •Patient with sensitivity and allergy with Yellow No. 5 (Sunset Yellow FCF)
- •8. In case of the principal investigator has determined that it is not suitable for this clinical trial due to reasons other than the above inclusion/exclusion criteria
- •9. In the case of female, those who are suspected of pregnancy or nursing
研究者
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