Study to Assess PK/PD Character, Safety/Tolerability of CKD-519 New Formulation in Healthy Male Subject.
NCT02623868 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2016-01-20
Summary
Study to assess the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability to CKD-519 new formulation in healthy male subjects.
Conditions
Interventions
- DRUG
-
CKD-519 50mg 2Tabs.
after taking Standard meal, CKD-519 50mg 2Tabs. administration.
- DRUG
-
CKD-519 100mg 1Tab.
after taking Standard meal, CKD-519 100mg 1Tab. administration.
- DRUG
-
CKD-519 100mg 1Cap.
after taking Standard meal, CKD-519 100mg 1Cap. administration.
Sponsors & Collaborators
-
Chong Kun Dang Pharmaceutical
lead INDUSTRY
Principal Investigators
-
Ji Young Kim, MD, PhD · Korea University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 20 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-10-31
- Primary Completion
- 2015-12-31
- Completion
- 2015-12-31
Countries
- South Korea
Study Locations
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