Cohort 1 To evaluate the pharmacokinetic interactions of CJ-12420 after multiple oral doses of CJ-12420 given alone or in combination with amoxicillin/clarithromycin in healthy subjects. Cohort 2 To evaluate the pharmacodynamic profiles of CJ-12420 after multiple oral doses of CJ-12420 in combination with amoxicillin/clarithromycin in healthy subjects as compared to an active control group, i.e., pantoprazole in combination with amoxicillin/clarithromycin.
To evaluate the pharmacokinetic the drug-drug interaction of CJ-12420 and amoxicillin/clarithromycin and investigate the pharmacodynamic of co-administration of CJ-12420 and amoxicillin and clarithromycin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
60
Cohort 1: bid for 5 days Cohort 2: bid for 7 days
Cohort 1: bid for 5 days Cohort 2: bid for 7 days
Cohort 2: bid for 7 days
Cohort 1: bid for 5 days Cohort 2: bid for 7 days
Cohort 2: bid for 7 days
Inje University Busan Baik Hospital
Busan, South Korea
Peak Plasma Concentration (Cmax) of CJ-12420, clarithromycin and amoxicillin
Time frame: Up to 120 hours
Area under the plasma concentration versus time curve (AUC) of CJ-12420, clarithromycin and amoxicillin
Time frame: Up to 120 hours
Time of maximum observed concentraion(tmax) of CJ-12420, clarithromycin and amoxicillin
Time frame: Up to 120 hours
Half life(t1/2) of CJ-12420, clarithromycin and amoxicillin
Time frame: Up to 120 hours
Oral clearance at steady state(CLss/F) of CJ-12420, clarithromycin and amoxicillin
Time frame: Up to 120 hours
Apparent volume of distribution at steady state(Vdss/F) of CJ-12420, clarithromycin and amoxicillin
Time frame: Up to 120 hours
median pH
Data from the pH probe monitoring
Time frame: Up to 24 hours
Time at pH > 3 (%)
the percent of time the pH as data from the pH probe monitoring
Time frame: Day -1, Day 1, Day 7 up to 24 hours
Time at pH > 4 (%)
the percent of time the pH as data from the pH probe monitoring
Time frame: Day -1, Day 1, Day 7 up to 24 hours
Time at pH > 6 (%)
the percent of time the pH as data from the pH probe monitoring
Time frame: Day -1, Day 1, Day 7 up to 24 hours
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