This study aims to evaluate the pharmacodynamics after single oral dosing of tegoprazan, EAPA115 and RAPA115 in healthy volunteers.
Evaluation Criteria * Pharmacodynamic assessments with intragastric pH * Safety assessments with adverse event monitoring including subjective/objective symptoms, physical examination, vital signs, electrocardiogram, and laboratory test
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Seoul National University Hospital, Clinical Trial Center
Seoul, South Korea
Pharmacodynamic Evaluation
The ratio of duration(Duration %) with pH ≥ 4 over 24 hours
Time frame: Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period
Pharmacodynamic Evaluation
The ratio of duration(Duration %) with pH ≥ 6 over 24 hours
Time frame: Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period
Pharmacodynamic Evaluation
Median pH
Time frame: Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period
Pharmacodynamic Evaluation
Mean pH
Time frame: Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period
Pharmacodynamic Evaluation
Baseline pH and changes in pH after the administration of investigational products (change of duration %, change of mean pH, change of median pH)
Time frame: Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period
Pharmacodynamic Evaluation
The ratio of duration(Duration %) with pH ≥ 4 during nocturnal period\* (\*12 hours after administration of investigational product)
Time frame: Pre-dose(0 hour) up to 12 hours after Investigational product administration in each period
Pharmacodynamic Evaluation
The ratio of duration(Duration %) with pH ≥ 6 during nocturnal period\* (\*12 hours after administration of investigational product)
Time frame: Pre-dose(0 hour) up to 12 hours after Investigational product administration in each period
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