The objective of this clinical trial is to explore pharmacodynamics and pharmacokinetics of YH4808 New Formulation in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
82
The number of times : multiple-dose Rout : oral administration
The number of times : multiple-dose Rout : oral administration
The number of times : multiple-dose Rout : oral administration
Yonsei Medical Center Severance Hospital Clinical Trials Center
Seoul, South Korea
The Cmax of YH4808
Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing
Time frame: Day 1(Day 35), Day 7(Day 41)
The AUC0-24h of YH4808
Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing
Time frame: Day 1(Day 35), Day 7(Day 41)
The AUC0-24h of M3
Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing
Time frame: Day 1(Day 35), Day 7(Day 41)
The Cmax of M3
Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing
Time frame: Day 1(Day 35), Day 7(Day 41)
the arithmetic mean of 24h intragastric pH monitoring
Time frame: Day 1(Day7)~Day2(Day8)
the median of 24h intragastric pH monitoring
Time frame: Day 1(Day7)~Day2(Day8)
The Duration of stomach maintained over pH4 or 5
Time frame: Day 1(Day7)~Day2(Day8)
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The number of times : multiple-dose Rout : oral administration