title: 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.
abstract: CDFR0209, 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.
authors.affiliation: Department of Family Practice and Community Health, Ajou University School of Medicine, Suwon, Republic of Korea.
authors.forename: Kyu-Nam
authors.initials: KN
authors.lastname: Kim
authors.affiliation: Department of Family Practice and Community Health, Ajou University School of Medicine, Suwon, Republic of Korea.
authors.forename: Sung-Won
authors.initials: SW
authors.lastname: Yang
authors.affiliation: CTCBIO Inc., Hwaseong, Republic of Korea.
authors.forename: Hyunil
authors.initials: H
authors.lastname: Kim
authors.affiliation: CTCBIO Inc., Hwaseong, Republic of Korea.
authors.forename: Seong Shin
authors.initials: SS
authors.lastname: Kwak
authors.affiliation: Department of Family Medicine, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea.
authors.forename: Young-Sang
authors.initials: YS
authors.lastname: Kim
authors.affiliation: Department of Clinical Pharmacology and Therapeutics, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea.
authors.forename: Doo-Yeoun
authors.initials: DY
authors.lastname: Cho
mesh_terms: D000328:Adult; D000897:Anti-Ulcer Agents / Q000494:pharmacology*; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations / Q000494:pharmacology; D004338:Drug Combinations; D005745:Gastric Acidity Determination; D064368:Healthy Volunteers; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D009853:Omeprazole / Q000494:pharmacology*; D054328:Proton Pump Inhibitors / Q000494:pharmacology*; D017693:Sodium Bicarbonate / Q000494:pharmacology*; D013270:Stomach / Q000737:chemistry / Q000187:drug effects*; D055815:Young Adult
chemical_list: D000897:Anti-Ulcer Agents; D003692:Delayed-Action Preparations; D004338:Drug Combinations; D054328:Proton Pump Inhibitors; D017693:Sodium Bicarbonate; D009853:Omeprazole
keywords: 24-hour pH monitoring; equivalence; immediate-release omeprazole; integrated gastric acidity; pharmacodynamics