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Acid Inhibitory Effect of a Combination of Omeprazole and Sodium Bicarbonate (CDFR0209) Compared With Delayed-Release Omeprazole 40 mg Alone in Healthy Adult Male Subjects

DC Field Value Language
dc.contributor.authorKim, KN-
dc.contributor.authorYang, SW-
dc.contributor.authorKim, H-
dc.contributor.authorKwak, SS-
dc.contributor.authorKim, YS-
dc.contributor.authorCho, DY-
dc.date.accessioned2019-11-13T04:26:46Z-
dc.date.available2019-11-13T04:26:46Z-
dc.date.issued2018-
dc.identifier.issn2160-763X-
dc.identifier.urihttp://repository.ajou.ac.kr/handle/201003/17484-
dc.description.abstractCDFR0209, a combination of an immediate-release formulation of omeprazole 40 mg and sodium bicarbonate 1100 mg, has been developed to treat acid-related disorders. We compared the acid inhibitory effects of CDFR0209 and delayed-release omeprazole (omeprazole-DR, Losec 40 mg) after repeated dosing in Helicobacter pylori-negative healthy adult male subjects. In this 2-period crossover study, 30 subjects were randomized to CDFR0209 or omeprazole-DR daily for 7 days. An ambulatory continuous 24-hour intragastric pH recording was performed at baseline and on days 1 and 7 of each administration period. Integrated gastric acidity was calculated from time-weighted average hydrogen ion concentrations at each hour of the 24-hour record. An analysis of variance model was used to test the pharmacodynamic equivalence of CDFR0209 and omeprazole-DR, using the natural logarithmic transformation of the percent decrease from baseline in integrated gastric acidity for the 24-hour interval after the seventh dose of each omeprazole formulation. The geometric least-squares mean ratios (CDFR0209/omeprazole-DR) of the percent decrease from baseline in integrated gastric acidity was 0.98 (90%CI, 0.93-1.07). Both CDFR0209 and omeprazole-DR are equally effective in decreasing integrated gastric acidity at steady state.-
dc.language.isoen-
dc.subject.MESHAdult-
dc.subject.MESHAnti-Ulcer Agents-
dc.subject.MESHCross-Over Studies-
dc.subject.MESHDelayed-Action Preparations-
dc.subject.MESHDrug Combinations-
dc.subject.MESHGastric Acidity Determination-
dc.subject.MESHHealthy Volunteers-
dc.subject.MESHHumans-
dc.subject.MESHHydrogen-Ion Concentration-
dc.subject.MESHMale-
dc.subject.MESHOmeprazole-
dc.subject.MESHProton Pump Inhibitors-
dc.subject.MESHSodium Bicarbonate-
dc.subject.MESHStomach-
dc.subject.MESHYoung Adult-
dc.titleAcid Inhibitory Effect of a Combination of Omeprazole and Sodium Bicarbonate (CDFR0209) Compared With Delayed-Release Omeprazole 40 mg Alone in Healthy Adult Male Subjects-
dc.typeArticle-
dc.identifier.pmid28111929-
dc.subject.keywordequivalence-
dc.subject.keyword24-hour pH monitoring-
dc.subject.keywordimmediate-release omeprazole-
dc.subject.keywordintegrated gastric acidity-
dc.subject.keywordpharmacodynamics-
dc.contributor.affiliatedAuthor김, 규남-
dc.type.localJournal Papers-
dc.identifier.doi10.1002/cpdd.331-
dc.citation.titleClinical pharmacology in drug development-
dc.citation.volume7-
dc.citation.number1-
dc.citation.date2018-
dc.citation.startPage53-
dc.citation.endPage58-
dc.identifier.bibliographicCitationClinical pharmacology in drug development, 7(1). : 53-58, 2018-
dc.embargo.liftdate9999-12-31-
dc.embargo.terms9999-12-31-
dc.identifier.eissn2160-7648-
dc.relation.journalidJ02160763X-
Appears in Collections:
Journal Papers > School of Medicine / Graduate School of Medicine > Family Practice & Community Health
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