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| Name | Class |
|---|---|
| Asan Medical Center | OTHER |
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The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of CJ-12420 after single and multiple dose administration according to H. pylori infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CJ-12420 50mg(HP-) | Experimental | CJ-12420 50mg in H. pylori negative subject |
|
| CJ-12420 100mg(HP-) | Experimental | CJ-12420 100mg in H. pylori negative subject |
|
| CJ-12420 50mg(HP+) | Experimental | CJ-12420 50mg in H. pylori positive subject |
|
| CJ-12420 100mg(HP+) | Experimental | CJ-12420 100mg in H. pylori positive subject |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CJ-12420 50mg(HP-) | Drug | CJ-12420 50mg in H. pylori negative subject |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of CJ-12420 | up to 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) of CJ-12420 | up to 12 hours | |
| Time of maximum observed concentration(tmax) of CJ-12420 | up to 12 hours | |
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Inclusion Criteria:
Healthy male volunteers between 20 to 45 years of age (inclusive)
Body mass index (BMI) in the range of 19~28 kg/㎡ and weighted at least 50kg
Medically healthy with no clinically significant vital signs (blood pressure in the sitting position, pulse rate)
Understood the requirements of the study and voluntarily consented to participate in the study
Agreed to be sexually abstinent or to use a condom or spermicide when engaging in sexual activity and not to donate sperm during the course of the study for 30 days following completion of the study
Non-smokers or non-users of nicotine-containing products for at least 1 year
[Cohort 1] H. pylori negative as determined by urea breath test and serum IgG antibody
[Cohort 2] H. pylori positive as determined by urea breath test and serum IgG
Exclusion Criteria:
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| CJ-12420 100mg(HP-) | Drug | CJ-12420 100mg in H. pylori negative subject |
|
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| CJ-12420 50mg(HP+) | Drug | CJ-12420 50mg in H. pylori positive subject |
|
|
| CJ-12420 100mg(HP+) | Drug | CJ-12420 100mg in H. pylori positive subject |
|
|
| Half life(t1/2β) of CJ-12420 |
| up to 12 hours |
| Mean pH | Data from the pH probe monitoring | 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 | 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 | Day -1, Day 1, Day 7 up to 24 hours |