Study to Compare the Safety and Pharmacokinetics of CKD-330 8/5mg With Coadministration of the Two Separate Drugs
NCT02548286 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53
Last updated 2015-12-07
Summary
The purpose of this study is to compare the safety and pharmacokinetics of CKD-330 (fixed-dose combination of Candesartan Cilexetil 8 mg and Amlodipine 5 mg) with coadministration of the two separate drugs in healthy male volunteers.
Conditions
Interventions
- DRUG
-
Candesartan 8mg
PO, 1day or 22day
- DRUG
-
Amlodipine 5mg
PO, 1day or 22day
- DRUG
-
CKD-330 8/5mg
PO, 1day or 22day
Sponsors & Collaborators
-
Chong Kun Dang Pharmaceutical
lead INDUSTRY
Principal Investigators
-
Jang Hee Hong, MD, PhD · Chungnam National University Hospital
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
- 2015-08-31
- Primary Completion
- 2015-08-31
- Completion
- 2015-09-30
Countries
- South Korea
Study Locations
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