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临床试验/NCT02484482
NCT02484482
已完成
1 期

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

Chong Kun Dang Pharmaceutical1 个研究点 分布在 1 个国家目标入组 45 人2015年6月

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

注册库
clinicaltrials.gov
开始日期
2015年6月
结束日期
2015年8月
最后更新
10年前
研究类型
Interventional
研究设计
Crossover
性别
All

研究者

责任方
Sponsor

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)

研究点 (1)

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