A randomized, double-blind, placebo-controlled, multiple-dose clinical trial to evaluate the safety/tolerability and pharmacokinetics, and pharmacodynamics after intravenous DWP14012 injection in healthy volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
33
1. Part 1 * Study drug: Daewoong Pharmaceutical Co., Ltd.; A mg, B mg, and C mg of DWP14012 inj. (40 mg/vial) * Control drug: Placebo (Normal saline) 2. Part 2 • Study drug: Daewoong Pharmaceutical Co., Ltd.; DWP14012 inj. (40 mg/vial)
Seoul-National University Hospital
Seoul, South Korea
AUC0-24h of Fexuprazan
Pharmacokinetics parameter following DWP14012 injection
Time frame: Part1 for 8 days, Part2 for 5 days
24h pH monitoring, the ratio of the time remaining above pH 4, 6 (time%)
Parmacodynamics parameter following DWP14012 injection
Time frame: Part1 for 8 days, Part2 for 4 days
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