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The objective of this study is not only to explore pharmacokinetic interaction after single oral administration but also pharmacodynamics interaction after multiple oral administration of YH4808, amoxicillin and clarithromycin each separately versus coadministration of YH4808, amoxicillin and clarithromycin in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YH4808, amoxicillin, clarithromycin | Experimental | single administration of YH4808 or amoxicillin or clarithromycin or YH4808 + amoxicillin + clarithromycin |
|
| YH4808, amoxicillin and clarithromycin | Experimental | 7 days repeat administration of YH4808, amoxicillin and clarithromycin for H.pylori eradication |
|
| YH4808 and amoxicillin | Experimental | 7 days repeat administration of YH4808 and amoxicillin for H.pylori eradication |
|
| nexium, amoxicillin and clarithromycin | Active Comparator | BID, 7 days repeat administration of nexium, amoxicillin and clarithromycin for H.pylori eradication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YH4808 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax, AUClast of YH4808, M3, amoxicillin, clarithromycin, 14-hydroxyclarithromycin | pre dose, 16 times after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax, AUClast of M8, AUCinf, t1/2, Tmax of YH4808, M3, M8, amoxicillin, clarithromycin, 14-hydroxyclarithromycin | pre dose, 16 times after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min soo Park, Ph.D, M.D. | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Severance Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33062627 | Derived | Park H, Kim CO, Kim M, Lim Y, Lee WY, Yoon S, Park MS. Pharmacodynamic evaluation of YH4808 for Helicobacter pylori eradication in healthy subjects. Transl Clin Pharmacol. 2020 Sep;28(3):136-146. doi: 10.12793/tcp.2020.28.e16. Epub 2020 Sep 23. | |
| 32274381 | Derived | Lee WY, Oh E, Cui M, Kim CO, Lim Y, Kim H, Park H, Yoon S, Park MS, Hong T. Evaluation of pharmacokinetic interactions between amoxicillin, clarithromycin, and the potassium-competitive acid blocker YH4808 in healthy subjects. Transl Clin Pharmacol. 2020 Mar;28(1):55-65. doi: 10.12793/tcp.2020.28.e5. Epub 2020 Mar 31. |
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| ID | Term |
|---|---|
| C000625316 | YH4808 |
| D015507 | Drugs, Investigational |
| D064098 | Esomeprazole |
| D000658 | Amoxicillin |
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
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| Nexium | Drug |
|
|
| Amoxicillin | Drug |
|
|
| clarithromycin | Drug |
|
|
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |