Study to Assess PK/PD Character, Safety/Tolerability of CKD-519 New Formulation in Healthy Male Subject.
NCT ID: NCT02623868
Last Updated: 2016-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2015-10-31
2015-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CKD-519
NCT03210649
Study to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CKD-519
NCT02753504
A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Male Volunteers
NCT03920579
A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-348(3)
NCT05192356
A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-386(2) 80/20/10mg
NCT04987970
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
A-B-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
CKD-519 50mg 2Tabs.
after taking Standard meal, CKD-519 50mg 2Tabs. administration.
CKD-519 100mg 1Tab.
after taking Standard meal, CKD-519 100mg 1Tab. administration.
CKD-519 100mg 1Cap.
after taking Standard meal, CKD-519 100mg 1Cap. administration.
Group 2
B-C-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
CKD-519 50mg 2Tabs.
after taking Standard meal, CKD-519 50mg 2Tabs. administration.
CKD-519 100mg 1Tab.
after taking Standard meal, CKD-519 100mg 1Tab. administration.
CKD-519 100mg 1Cap.
after taking Standard meal, CKD-519 100mg 1Cap. administration.
Group 3
C-A-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
CKD-519 50mg 2Tabs.
after taking Standard meal, CKD-519 50mg 2Tabs. administration.
CKD-519 100mg 1Tab.
after taking Standard meal, CKD-519 100mg 1Tab. administration.
CKD-519 100mg 1Cap.
after taking Standard meal, CKD-519 100mg 1Cap. administration.
Group 4
A-C-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
CKD-519 50mg 2Tabs.
after taking Standard meal, CKD-519 50mg 2Tabs. administration.
CKD-519 100mg 1Tab.
after taking Standard meal, CKD-519 100mg 1Tab. administration.
CKD-519 100mg 1Cap.
after taking Standard meal, CKD-519 100mg 1Cap. administration.
Group 5
B-A-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
CKD-519 50mg 2Tabs.
after taking Standard meal, CKD-519 50mg 2Tabs. administration.
CKD-519 100mg 1Tab.
after taking Standard meal, CKD-519 100mg 1Tab. administration.
CKD-519 100mg 1Cap.
after taking Standard meal, CKD-519 100mg 1Cap. administration.
Group 6
C-B-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
CKD-519 50mg 2Tabs.
after taking Standard meal, CKD-519 50mg 2Tabs. administration.
CKD-519 100mg 1Tab.
after taking Standard meal, CKD-519 100mg 1Tab. administration.
CKD-519 100mg 1Cap.
after taking Standard meal, CKD-519 100mg 1Cap. administration.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CKD-519 50mg 2Tabs.
after taking Standard meal, CKD-519 50mg 2Tabs. administration.
CKD-519 100mg 1Tab.
after taking Standard meal, CKD-519 100mg 1Tab. administration.
CKD-519 100mg 1Cap.
after taking Standard meal, CKD-519 100mg 1Cap. administration.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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 \<100mmHg or \>140mmHg, diastolic blood pressure\<60mmHg or \>90mmHg
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
20 Years
45 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ji Young Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Korea University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Korea university medical center
Seoul, Sungbuk-gu, South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
148NF15010
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.