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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CJ-12420 100mg | Experimental | CJ-12420 100mg BID for 5 days |
|
| CJ-12420 50mg + CLR 500mg + AMX 1g | Experimental | coadministration of CJ-12420 50mg and CLR 500mg/AMX 1g BID for 7 days |
|
| Pantoprazole 40mg + CLR 500mg + AMX 1g | Active Comparator | coadministration of Pantoprazole 40mg and CLR 500mg/AMX 1g BID for 7 days |
|
| CJ-12420 100mg + CLR 500mg + AMX 1g | Experimental | coadministration of CJ-12420 100mg, CLR 500mg/AMX 1g BID for 7 days |
|
| CLR 500mg/AMX 1g | Experimental | CLR 500mg/AMX 1g BID for 5 days |
|
| CJ-12420 100mg + CLR 500mg/AMX 1g |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLR 500mg | Drug | Cohort 1: bid for 5 days Cohort 2: bid for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of CJ-12420, clarithromycin and amoxicillin | Up to 120 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) of CJ-12420, clarithromycin and amoxicillin | Up to 120 hours | |
| Time of maximum observed concentraion(tmax) of CJ-12420, clarithromycin and amoxicillin | Up to 120 hours |
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Inclusion Criteria:
Exclusion Criteria:
Medical history
Laboratory tests and ECG
Allergy and drug abuse
Drug/dietary restrictions
Blood donation and transfusion
Pregnancy and contraception
Others
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| Name | Affiliation | Role |
|---|---|---|
| Jae-Gook Shin | Inje university college of medicine Busan Paik Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Busan Baik Hospital | Busan | South Korea |
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| ID | Term |
|---|---|
| D017291 | Clarithromycin |
| D000658 | Amoxicillin |
| D000077402 | Pantoprazole |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Experimental |
coadministration of CJ-12420 100mg and CLR 500mg/AMX 1g BID for 7 days |
|
|
| CJ-12420 100mg | Drug | Cohort 1: bid for 5 days Cohort 2: bid for 7 days |
|
| CJ-12420 50mg | Drug | Cohort 2: bid for 7 days |
|
| AMX 1g | Drug | Cohort 1: bid for 5 days Cohort 2: bid for 7 days |
|
|
| Pantoprazole 40mg | Drug | Cohort 2: bid for 7 days |
|
| Half life(t1/2) of CJ-12420, clarithromycin and amoxicillin | Up to 120 hours |
| Oral clearance at steady state(CLss/F) of CJ-12420, clarithromycin and amoxicillin | Up to 120 hours |
| Apparent volume of distribution at steady state(Vdss/F) of CJ-12420, clarithromycin and amoxicillin | Up to 120 hours |
| median pH | Data from the pH probe monitoring | Up to 24 hours |
| Time at pH > 3 (%) | 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 > 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 |
| Organic Chemicals |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |