A Randomized, Open-label, Single Dose, 3-treatment, 3-period, 6-sequence Crossover Study to Investigate the Effect of Food on the Pharmacokinetics/Pharmacodynamics and Safety of CKD-519 After Oral Administration in Healthy Adult Volunteers
概览
- 阶段
- 1 期
- 干预措施
- CKD-519 200mg / Fasting, Standard Meal, High Fat Meal
- 疾病 / 适应症
- Dyslipidemia
- 发起方
- Chong Kun Dang Pharmaceutical
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Area under the plasma drug concentration-time curve(AUC0-last) of CKD-519
- 状态
- 已完成
- 最后更新
- 10年前
概览
简要总结
The purpose this study investigate the effect of food on the pharmacokinetics/pharmacodynamics and safety of CKD-519
研究者
入排标准
入选标准
- •Between 19 aged and 55 aged in healthy adult
- •Body weight more than 55kg in male, 50kg in female
- •Body Mass Index more than 18.5 and under 25(body mass index=kg/m2)
- •If female, must include more than one among the items
- •The menopause(there is no natural menses for at least 2 years)
- •Surgical Infertility(hysterectomy or bilateral oophorectomy, tubal ligation or other methods of infertility condition)
- •If men has sexual life with women of childbearing age, Necessarily he agrees that use condoms and do not sperm donation until two months during clinical trials and after the final dosage of investigational products
- •Those who fully understand about this clinical trials after enough hearing, and then decided to join the clinical trials by themselves and to comply with the precautions written consent
排除标准
- •Have clinically significant disease that hepatobiliary system(severe hepatic impairment, etc.), kidney(severe renal impairment, etc.), nervous system, immune system, respiratory system, endocrine system, haemato-oncology disease, cardiovascular system(heart failure, etc.) or mental illness, or a history of mental disease.
- •Have a gastrointestinal disease history that can effect drug absorption(Crohn's disease, ulcers, etc.) or surgery(except simple appendectomy or hernia surgery)
- •Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of drugs or additives.
- •An impossible one who participates in clinical trial including screening tests (medical history taking, BP, 12-lead ECG, physical examination, blood\&urine laboratory test result) before 28 days the taking investigational products.
- •Defined by the following laboratory parameters
- •AST(Aspartate aminotransferase), ALT(Alanine aminotransferase)\>1.25\* upper limit of normal range
- •Total bilirubin\>1.5\* upper limit of normal range
- •CPK(Creatine phosphokinase)\>1.5\* upper limit of normal range
- •eGFR(Estimated Glomerular Filtration Rate, using by MDRD(Modification of Diet in Renal Disease) method)\<60 mL/min/1.73m2
- •Sitting SBP(Systolic Blood Pressure )\>150 mmHg or \<90 mmHg, sitting DBP(Diastolic Blood Pressure )\>100 mmHg or 50 mmHg , after 5 minutes break.
研究组 & 干预措施
Group 1
CKD-519 200mg administration, subjects have a Fasting, Standard Meal, High Fat Meal by randomized group. Fasting→Standard Meal→High Fat Meal
干预措施: CKD-519 200mg / Fasting, Standard Meal, High Fat Meal
Group 2
CKD-519 200mg administration, subjects have a Fasting, Standard Meal, High Fat Meal by randomized group. Standard Meal→High Fat Meal→Fasting
干预措施: CKD-519 200mg / Fasting, Standard Meal, High Fat Meal
Group 3
CKD-519 200mg administration, subjects have a Fasting, Standard Meal, High Fat Meal by randomized group. High Fat Meal→Fasting→Standard Meal
干预措施: CKD-519 200mg / Fasting, Standard Meal, High Fat Meal
Group 4
CKD-519 200mg administration, subjects have a Fasting, Standard Meal, High Fat Meal by randomized group. Fasting→High Fat Meal→Standard Meal
干预措施: CKD-519 200mg / Fasting, Standard Meal, High Fat Meal
Group 5
CKD-519 200mg administration, subjects have a Fasting, Standard Meal, High Fat Meal by randomized group. Standard Meal→Fasting→High Fat Meal
干预措施: CKD-519 200mg / Fasting, Standard Meal, High Fat Meal
Group 6
CKD-519 200mg administration, subjects have a Fasting, Standard Meal, High Fat Meal by randomized group. High Fat Meal→Standard Meal→Fasting
干预措施: CKD-519 200mg / Fasting, Standard Meal, High Fat Meal
结局指标
主要结局
Area under the plasma drug concentration-time curve(AUC0-last) of CKD-519
时间窗: 0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
Tmax of CKD-519
时间窗: 0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
Cmax of CKD-519
时间窗: 0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
AUC0-∞ of CKD-519
时间窗: 0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
T1/2 of CKD-519
时间窗: 0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
CL/F(Clearance/Bioavailability) of CKD-519
时间窗: 0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
Vd/F of CKD-519
时间窗: 0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
次要结局
- Inhibition of CETP(Cholesteryl ester transfer protein) Activity(0(predose), 1, 2, 4, 6, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168)