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
Overview
- Phase
- Phase 1
- Intervention
- CKD-519 200mg / Fasting, Standard Meal, High Fat Meal
- Conditions
- Dyslipidemia
- Sponsor
- Chong Kun Dang Pharmaceutical
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Area under the plasma drug concentration-time curve(AUC0-last) of CKD-519
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose this study investigate the effect of food on the pharmacokinetics/pharmacodynamics and safety of CKD-519
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
Group 1
CKD-519 200mg administration, subjects have a Fasting, Standard Meal, High Fat Meal by randomized group. Fasting→Standard Meal→High Fat Meal
Intervention: 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
Intervention: 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
Intervention: 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
Intervention: 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
Intervention: 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
Intervention: CKD-519 200mg / Fasting, Standard Meal, High Fat Meal
Outcomes
Primary Outcomes
Area under the plasma drug concentration-time curve(AUC0-last) of CKD-519
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168
Secondary Outcomes
- 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)