To compare pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382 and D026 in healthy subjects
A randomized, open-label, crossover phase 1 clinical trial to compare pharmacokinetics, pharmacodynamics and safety after single / multiple administration of CKD-382 and D026 in healthy subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
1 tablet administered under fasting condition for 7days
1 tablet administered under fasting condition for 7days
1 tablet administered under fasting condition for 7days
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
RECRUITINGAUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state) Evaluation PK after multiple dose
Time frame: 0~24h
Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose Evaluation PD for ambulatory 24hr pH monitor
Time frame: Baseline versus Multiple dose during 7 days
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