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Primary Objective: To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.
Secondary Objective(s): To assess the safety of the coadministration of multiple dose of CJ-12420 and clarithromycin in healthy subjects
An open-label, randomized, 6-sequence, 3-period, 3-treatment crossover design
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CJ-12420 200 mg + Clarithromycin 500mg | Experimental | CJ-12420 200mg QD for 5 days + Clarithromycin 500mg BID for 5 days |
|
| CJ-12420 200mg | Active Comparator | CJ-12420 200mg QD for 5 days |
|
| Clarithromycin 500mg | Active Comparator | Clarithromycin 500mg BID for 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CJ-12420 200mg + Clarithromycin 500mg | Drug | To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin. |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin | Cmax, Cmin, Tmax, AUC(tau), CL/F, T1/2 | Blood sampling during 12 or 24hrs after administration |
| Measure | Description | Time Frame |
|---|---|---|
| The safety of the coadministration of multiple dose of CJ-12420 and clarithromycin in healthy subjects | Safety and tolerability parameters will include laboratory (haematology, clinical chemistry, urinalysis, 12-lead ECG) values at Screening, Day-1 and Day 6 at each period and Follow-up. | 6 days after last visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje university college of medicine Busan Paik Hospital | Busan | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37440779 | Derived | Oh M, Lee H, Kim S, Kim B, Song GS, Shin JG, Ghim JL. Evaluation of pharmacokinetic drug-drug interaction between tegoprazan and clarithromycin in healthy subjects. Transl Clin Pharmacol. 2023 Jun;31(2):114-123. doi: 10.12793/tcp.2023.31.e11. Epub 2023 Jun 27. |
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| ID | Term |
|---|---|
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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|
| CJ-12420 200mg | Drug | To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin. |
|
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| Clarithromycin 500mg | Drug | To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin. |
|
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| Organic Chemicals |