Cited 10 times in
The safety, pharmacodynamics, and pharmacokinetics of immediate-release formulation containing esomeprazole 20 mg/sodium bicarbonate 800 mg in healthy adult male
DC Field | Value | Language |
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dc.contributor.author | 박민수 | - |
dc.contributor.author | 류병원 | - |
dc.contributor.author | 김춘옥 | - |
dc.contributor.author | 홍태곤 | - |
dc.date.accessioned | 2019-10-28T01:53:51Z | - |
dc.date.available | 2019-10-28T01:53:51Z | - |
dc.date.issued | 2019 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/171391 | - |
dc.description.abstract | Background: Esomeprazole is the most effective treatment for acid-related disorders and is widely used with enteric coating due to rapid degradation in the acidic environment. However, the enteric-coated formulation delays absorption and onset of action. To overcome this limitation, an immediate-release formulation containing esomeprazole 20 mg and sodium bicarbonate 800 mg (IR-ESO) was developed. Purpose: To evaluate the safety, pharmacokinetics (PK), and pharmacodynamics of IR-ESO compared to those of esomeprazole 20 mg (ESO). Methods: A randomized, open-label, multiple-dose, two-treatment, two-sequence crossover study was conducted in 40 healthy male subjects. Subjects received either IR-ESO or ESO for 7 days. After single and multiple dosing, blood samples were collected for PK analysis, and intragastric pH was assessed by 24-hr pH monitoring. Results: Plasma esomeprazole exposure of IR-ESO was similar to that of ESO after single and multiple dosing. Time to peak concentration of IR-ESO (0.50-0.75 hr) was shorter than that of ESO (1.25-1.50 hr). Percentage changes in 24-hr integrated gastric acidity from baseline for IR-ESO were similar to those for ESO. In addition, mean time to maintain gastric pH >4 for 24 hr was similar for both drugs (IR-ESO 55.5-69.9% vs ESO 56.8-70.2%). Evaluation of time to first reach pH 4 after dosing indicated that IR-ESO showed a faster onset than ESO. All subjects found the drug tolerable, and there were no significant differences in adverse events between two drugs. Conclusion: This study showed that IR-ESO produced a rapid, safe and sustained gastric acid suppression (ClinicalTrials.gov: NCT03211143). | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Dove Press Limited | - |
dc.relation.isPartOf | Drug Design, Development and Therapy | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.title | The safety, pharmacodynamics, and pharmacokinetics of immediate-release formulation containing esomeprazole 20 mg/sodium bicarbonate 800 mg in healthy adult male | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Pediatrics (소아청소년과학교실) | - |
dc.contributor.googleauthor | Dasohm Kim | - |
dc.contributor.googleauthor | Min Soo Park | - |
dc.contributor.googleauthor | Byung Won Yoo | - |
dc.contributor.googleauthor | Taegon Hong | - |
dc.contributor.googleauthor | Shin Jung Park | - |
dc.contributor.googleauthor | Choon Ok Kim | - |
dc.identifier.doi | 10.2147/DDDT.S212491 | - |
dc.contributor.localId | A01468 | - |
dc.contributor.localId | A02468 | - |
dc.contributor.localId | A04735 | - |
dc.contributor.localId | A05194 | - |
dc.relation.journalcode | J02859 | - |
dc.identifier.eissn | 1177-8881 | - |
dc.identifier.pmid | 31564831 | - |
dc.subject.keyword | 24-hr pH monitoring | - |
dc.subject.keyword | esomeprazole | - |
dc.subject.keyword | immediate-release esomeprazole | - |
dc.subject.keyword | sodium bicarbonate | - |
dc.contributor.alternativeName | Park, Min Soo | - |
dc.contributor.affiliatedAuthor | 박민수 | - |
dc.contributor.affiliatedAuthor | 류병원 | - |
dc.contributor.affiliatedAuthor | 김춘옥 | - |
dc.contributor.affiliatedAuthor | 홍태곤 | - |
dc.citation.volume | 13 | - |
dc.citation.startPage | 3151 | - |
dc.citation.endPage | 3159 | - |
dc.identifier.bibliographicCitation | Drug Design, Development and Therapy, Vol.13 : 3151-3159, 2019 | - |
dc.identifier.rimsid | 64344 | - |
dc.type.rims | ART | - |
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