Clinical trial to assess the pharmacokinetic/Pharmacodynamic characteristics and safety/tolerability of CKD-519 new formulation in healthy male subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0001729

Enrollment

Registered

2015-12-14

Start date

2015-11-13

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : -Group 1: CKD-519 50mg 2Tab. ?CKD-519 100mg 1Tab.?CKD-519 100mg 1Cap. -Group 2: CKD-519 100mg 1Tab.?CKD-519 100mg 1Cap. ? CKD-519 50mg 2Tab. -Group 3: CKD-519 100mg 1Cap. ? CKD-519 50mg 2Ta

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1.Between 20 aged and 45 aged in healthy male adult 2.Body weight = 50kg and in the range of calculated BMI(Body Mass Index) 18~29kg/m2 3.Subject who sign on an informed consent form willingly 4.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

Exclusion criteria

Exclusion criteria: 1.Clinically significant disease with cardiovascular, respiratory, hepatobiliary, nephrological, hematological, gastrointestinal, endocrine, immune, integumentary, neurologic, psychiatric system 2.Have a acute disease within 28 days before the beginning of study treatment 3.Have a disease history that can effect drug absorption, distribution, metabolism, excretion 4.Have a clinically significant chronic disease 5.Systolic blood pressure 140mmHg, diastolic blood pressure90mmHg 6.Positive for serology test (HBsAg, anti-HCV Ab, anti-HIV Ab, VDRL(Venereal Disease Research Laboratories)) 7.Subject treated ethical drug within 14 days before the beginning of study treatment 8.Subject treated over-the-counter or herbal medicine within 7 days before the beginning of study treatment 9.Have a clinically significant allergic disease (except for mild allergic rhinitis, allergic dermatitis with no drugs) 10.Cannot take standard Meal 11.Whole blood donation within 60 days prior to the first dosing or component blood donation within 20 days prior to the first dosing 12.Blood transfusion within 30 days 13.Taking drugs have received any other investigational drug within 90 days prior to the first dosing 14.Continuously taking caffeine(>5 cups/day), drinking alcohol(>30g/day), smoking excessive cigarettes(>10cigarettes/day) 15.Impossible on who participants in clinical trial by investigator's decision including laboratory test result or another reasone(for example, noncompliance, a disobliging manner) 16.Subject treated metabolizing enzyme inducers or inhibitors including barbiturates within 30 days

Design outcomes

Primary

Measure	Time frame
Cmax of CKD-519 ;Tmax of CKD-519;AUClast of CKD-519 ;AUC0-8 of CKD-519 ;t1/2 of CKD-519;CL/F of CKD-519;Vd/F of CKD-519	—

Secondary

Measure	Time frame
Tmax of CKD-519 CETP(Cholesteryl ester transfer protein) Activity ;Emax of CKD-519 CETP Activity ;AUEC of CKD-519 CETP Activity ;EC50(half maximal effective concentration ) of CKD-519 CETP Activity	—

Countries

Korea, Republic of

Contacts

Public ContactJi-Young Park

Korea University Anam Hospital

gagamelinlove@gmail.com

Outcome results