A Randomized, Open-label, Single Dose, 1-sequence, 3-treatment, 3-period Crossover Study to Investigate the Effects of Food on the Pharmacokinetics/Pharmacodynamics of CKD-519 in Healthy Male Subjects
Overview
- Phase
- Phase 1
- Intervention
- CKD-519 100mg
- Conditions
- Healthy Volunteers
- Sponsor
- Chong Kun Dang Pharmaceutical
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Tmax of CKD-519
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to investigate the effects of food on the pharmacokinetics/pharmacodynamics of CKD-519.
Detailed Description
A randomized, open-label, single dose, 1-sequence, 3-treatment, 3-period crossover study to investigate the effects of food on the pharmacokinetics/pharmacodynamics of CKD-519 in healthy male subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Between 20 aged and 45 aged in healthy adult male
- •Body weight more than 50, Body Mass Index between 18 and 29kg/m²
- •Necessarily he agrees that use double contraceptions 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
- •Clinically significant disease with cardiovascular, respiratory, hepatobiliary, nephrological, hematological, gastrointestinal, endocrine, immune, integumentary, neurologic, psychiatric system
- •Have a acute disease within 28 days before the beginning of study treatment
- •Have a disease history that can effect drug absorption, distribution, metabolism, excretion
- •Have a clinically significant chronic disease
- •Systolic blood pressure\<100mmHg or\>140mmHg, diastolic blood pressure\<60mmHg or\>90mmHg
- •Defined by the following 12-lead ECG, QTc\>450msec
- •Positive for serology test (HBsAg, anti-HCV Ab, anti-HIV Ab, VDRL(Venereal Disease Research Laboratories))
- •Subject treated ethical drug within 14 days before the beginning of study treatment
- •Subject treated over-the-counter or herbal medicine within 7 days before the beginning of study treatment
- •Have a clinically significant allergic disease (except for mild allergic rhinitis, allergic dermatitis with no drugs)
Arms & Interventions
CKD-519 tablet 100mg
CKD-519 tablet(formulation Ⅱ) 100mg(100mg X 1Tab) Period 1: CKD-519 100mg in fasted state Period 2:CKD-519 100mg with a standard meal Period 3:CKD-519 100mg with a high fat meal
Intervention: CKD-519 100mg
CKD-519 tablet 200mg
CKD-519 tablet(formulation Ⅱ) 200mg(100mg X 2Tabs) Period 1:CKD-519 200mg in fasted state Period 2:CKD-519 200mg with a standard meal Period 3:CKD-519 200mg with a high fat meal
Intervention: CKD-519 200mg
CKD-519 soft capsule 100mg
CKD-519 soft capsule(formulation Ⅲ) 100mg(100mg X 1Cap) Period 1:CKD-519 100mg in fasted state Period 2:CKD-519 100mg with a standard meal Period 3:CKD-519 100mg with a high fat meal
Intervention: CKD-519 100mg
CKD-519 soft capsule 200mg
CKD-519 soft capsule(formulation Ⅲ) 200mg(100mg X 2Caps) Period 1:CKD-519 200mg in fasted state Period 2:CKD-519 200mg with a standard meal Period 3:CKD-519 200mg with a high fat meal
Intervention: CKD-519 200mg
Outcomes
Primary Outcomes
Tmax of CKD-519
Time Frame: 0(predose)~168
CL/F of CKD-519
Time Frame: 0(predose)~168
Cmax of CKD-519
Time Frame: 0(predose)~168
AUCinf of CKD-519
Time Frame: 0(predose)~168
T1/2 of CKD-519
Time Frame: 0(predose)~168
AUClast of CKD-519
Time Frame: 0(predose)~168
Vd/F of CKD-519
Time Frame: 0(predose)~168
Secondary Outcomes
- Inhibition of CETP(Cholesteryl ester transfer protein) Activity(0(predose)~168)