1. To evaluate the pharmacokinetic and pharmacodynamics characteristics after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions 2. To evaluate the safety and drug tolerance after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions
1. It is analyzed for subjects who receive scheduled clinical trial drugs according to the clinical trial plan, have no significant violations in comparative analysis, and have completed all scheduled blood collection for pharmacokinetic evaluation. To analyze subjects who receive clinical trial medications scheduled according to the clinical trial plan, have no significant violations in comparative analysis, and have assessable intragastric pH information by completing a 24-h pH monitoring measurement. 2. All subjects who received more than one dose of clinical trial drugs are evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
44
Test Drug: single administration of JW0301 Reference Drug: single administration of C2105 Tablet, Oral, QD for 1 Days, Washout period is more than 14 days after administration
Clinical Trial Center, Seoul National University Hospital
Seoul, South Korea
AUCτ, SS(Area under the plasma drug concentration-time curve within a dosing interval at steady state)
Evaluation PK for Esomeprazole 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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