A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Male Volunteers
NCT03920579 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2019-04-19
Summary
a study to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers
Conditions
- Hypertension
- Dyslipidemias
Interventions
- DRUG
-
CKD-386 formulation 1
A single oral dose of 1 tablet under fasting conditions for each period
- DRUG
-
CKD-386 formulation 2
A single oral dose of 1 tablet under fasting conditions for each period
- DRUG
-
D326, D337 and D013
A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period
Sponsors & Collaborators
-
Chong Kun Dang Pharmaceutical
lead INDUSTRY
Principal Investigators
-
Dongseong Shin, M.D, Ph.D · Clinical Trials Center, Gil Medical Center, Incheon, Korea
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 19 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-04-01
- Primary Completion
- 2019-05-31
- Completion
- 2019-05-31
Countries
- South Korea
Study Locations
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