Comparative Pharmacokinetics/Pharmacodynamics of Fixed-Dose Combination of Esomeprazole and Calcium Carbonate (AD-206) to the Conventional Esomeprazole

References

• VakilN, van ZantenSV, KahrilasP, DentJ, JonesR. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006;101(8):1900–20;quiz 1943. doi:10.1111/j.1572-0241.2006.00630.x
   Web of Science ®Google Scholar
• DentJ, El-SeragHB, WallanderMA, JohanssonS. Epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut. 2005;54(5):710–717. doi:10.1136/gut.2004.05182115831922
   PubMed Web of Science ®Google Scholar
• ScarpignatoC, GattaL, ZulloA, et al. Effective and safe proton pump inhibitor therapy in acid-related diseases - a position paper addressing benefits and potential harms of acid suppression. BMC Med. 2016;14(1):179. doi:10.1186/s12916-016-0718-z27825371
   PubMed Web of Science ®Google Scholar
• JamesOF, Parry-BillingsKS. Comparison of omeprazole and histamine H2-receptor antagonists in the treatment of elderly and young patients with reflux oesophagitis. Age Ageing. 1994;23(2):121–126. doi:10.1093/ageing/23.2.1218023719
   PubMed Web of Science ®Google Scholar
• KoopH, ScheppW, DammannHG, SchneiderA, LühmannR, ClassenM. Comparative trial of pantoprazole and ranitidine in the treatment of reflux esophagitis. Results of a German multicenter study. J Clin Gastroenterol. 1995;20(3):192–195. doi:10.1097/00004836-199504000-000057797824
   PubMed Web of Science ®Google Scholar
• JeeSR, SeolSY, KimDH, et al. [A randomized, comparative study of rabeprazole vs. ranitidine maintenance therapies for reflux esophagitis–multicenter study]. Korean J Gastroenterol. 2005;45(5):321–327. Korean.15908764
   PubMedGoogle Scholar
• Norman HansenA, BergheimR, FagertunH, LundH, MoumB. A randomised prospective study comparing the effectiveness of esomeprazole treatment strategies in clinical practice for 6 months in the management of patients with symptoms of gastroesophageal reflux disease. Int J Clin Pract. 2005;59(6):665–671. doi:10.1111/j.1368-5031.2005.00564.x15924594
   PubMed Web of Science ®Google Scholar
• ParkCH, LeeSK. [Gastroesophageal Reflux Disease]. Korean J Gastroenterol. 2019;73(2):70–76. Korean. doi:10.4166/kjg.2019.73.2.7030845382
   PubMedGoogle Scholar
• QiQ, WangR, LiuL, ZhaoF, WangS. Comparative effectiveness and tolerability of esomeprazole and omeprazole in gastro-esophageal reflux disease: a systematic review and meta-analysis. Int J Clin Pharmacol Ther. 2015;53(10):803–810. doi:10.5414/cp20239626329348
   PubMed Web of Science ®Google Scholar
• TutunjiMF, QaisiAM, El-EswedB, TutunjiLF. An in vitro investigation on acid catalyzed reactions of proton pump inhibitors in the absence of an electrophile. Int J Pharm. 2006;323(1–2):110–116. doi:10.1016/j.ijpharm.2006.05.05716860502
   PubMed Web of Science ®Google Scholar
• Van NguyenH, BaekN, LeeBJ. Enhanced gastric stability of esomeprazole by molecular interaction and modulation of microenvironmental pH with alkalizers in solid dispersion. Int J Pharm. 2017;523(1):189–202. doi:10.1016/j.ijpharm.2017.03.04728342789
   PubMed Web of Science ®Google Scholar
• HornJR, HowdenCW. Review article: similarities and differences among delayed-release proton-pump inhibitor formulations. Aliment Pharmacol Ther. 2005;22(Suppl 3):20–24. doi:10.1111/j.1365-2036.2005.02714.x
   PubMed Web of Science ®Google Scholar
• CastellD. Review of immediate-release omeprazole for the treatment of gastric acid-related disorders. Expert Opin Pharmacother. 2005;6(14):2501–2510. doi:10.1517/14656566.6.14.250116259581
   PubMed Web of Science ®Google Scholar
• HowdenCW. Review article: immediate-release proton-pump inhibitor therapy–potential advantages. Aliment Pharmacol Ther. 2005;22(Suppl 3):25–30. doi:10.1111/j.1365-2036.2005.02709.x16303034
   PubMed Web of Science ®Google Scholar
• KimD, ParkMS, YooBW, HongT, ParkSJ, KimCO. The safety, pharmacodynamics, and pharmacokinetics of immediate-release formulation containing esomeprazole 20 mg/sodium bicarbonate 800 mg in healthy adult male. Drug Des Devel Ther. 2019;13:3151–3159. doi:10.2147/dddt.S212491
   PubMed Web of Science ®Google Scholar
• JingS, ZhuY, LiuW, et al. Pharmacokinetics and pharmacodynamics of esomeprazole/sodium bicarbonate immediate-release capsules in healthy Chinese volunteers: a cross-over, randomized controlled trial. Adv Ther. 2021;38(3):1660–1676. doi:10.1007/s12325-021-01644-733575950
   PubMed Web of Science ®Google Scholar
• WashingtonN. Antacids and Anti Reflux Agents. Taylor & Francis; 1991.
   Google Scholar
• BruntonL, ChabnerBA, KnollmanB. Goodman and Gilman’s the Pharmacological Basis of Therapeutics. 12th ed. McGraw-Hill Education; 2011.
   Google Scholar
• SostekMB, ChenY, AnderssonT. Effect of timing of dosing in relation to food intake on the pharmacokinetics of esomeprazole. Br J Clin Pharmacol. 2007;64(3):386–390. doi:10.1111/j.1365-2125.2007.02889.x17425628
   PubMed Web of Science ®Google Scholar
• UllahMA, ShamsUD, MarufAA, et al. Relative bioavailability and pharmacokinetic properties of two different enteric formulations of esomeprazole in healthy bangladeshi male volunteers: an open-label, single-dose, randomized-sequence, two-way crossover study. Clin Ther. 2010;32(7):1419–1426. doi:10.1016/j.clinthera.2010.07.00720678688
   PubMed Web of Science ®Google Scholar
• IslamMS, AkterN, ShohagH, et al. Bioequivalence evaluation of two esomeprazole 20 mg capsule formulations in healthy male Bangladeshi volunteers. J Bioequiv Availab. 2011;3(6):139‐143. doi:10.4172/jbb.1000074
   Google Scholar
• KaniwaN, AoyagiN, OgataH, EjimaA, MotoyamaH, YasumiH. Gastric emptying rates of drug preparations. II. Effects of size and density of enteric-coated drug preparations and food on gastric emptying rates in humans. J Pharmacobiodyn. 1988;11(8):571–575. doi:10.1248/bpb1978.11.5713236215
   PubMedGoogle Scholar
• KhoslaR, DavisSS. The effect of tablet size on the gastric emptying of non-disintegrating tablets. Int J Pharm. 1990;62(2):R9–R11. doi:10.1016/0378-5173(90)90243-W
   Web of Science ®Google Scholar
• KellyK, O’MahonyB, LindsayB, et al. Comparison of the rates of disintegration, gastric emptying, and drug absorption following administration of a new and a conventional paracetamol formulation, using gamma scintigraphy. Pharm Res. 2003;20(10):1668–1673. doi:10.1023/a:102615582212114620524
   PubMed Web of Science ®Google Scholar
• WallsC, LewisA, BullmanJ, et al. Pharmacokinetic profile of a new form of sumatriptan tablets in healthy volunteers. Curr Med Res Opin. 2004;20(6):803–809. doi:10.1185/03007990412500358415200736
   PubMed Web of Science ®Google Scholar
• SheftellFD, DahlöfCG, BrandesJL, AgostiR, JonesMW, BarrettPS. Two replicate randomized, double-blind, placebo-controlled trials of the time to onset of pain relief in the acute treatment of migraine with a fast-disintegrating/rapid-release formulation of sumatriptan tablets. Clin Ther. 2005;27(4):407–417. doi:10.1016/j.clinthera.2005.04.00315922814
   PubMed Web of Science ®Google Scholar
• ShoukriRA, AhmedIS, ShammaRN. In vitro and in vivo evaluation of nimesulide lyophilized orally disintegrating tablets. Eur J Pharm Biopharm. 2009;73(1):162–171. doi:10.1016/j.ejpb.2009.04.00519406232
   PubMed Web of Science ®Google Scholar
• BenettiC, FlamminiL, VivoV, et al. Esomeprazole immediate release tablets: gastric mucosa ex vivo permeation, absorption and antisecretory activity in conscious rats. J Control Release. 2016;239:203–210. doi:10.1016/j.jconrel.2016.08.03227574989
   PubMed Web of Science ®Google Scholar
• ShiS, KlotzU. Proton pump inhibitors: an update of their clinical use and pharmacokinetics. Eur J Clin Pharmacol. 2008;64(10):935–951. doi:10.1007/s00228-008-0538-y18679668
   PubMed Web of Science ®Google Scholar
• KatzPO, KochFK, BallardED, et al. Comparison of the effects of immediate-release omeprazole oral suspension, delayed-release lansoprazole capsules and delayed-release esomeprazole capsules on nocturnal gastric acidity after bedtime dosing in patients with night-time GERD symptoms. Aliment Pharmacol Ther. 2007;25(2):197–205. doi:10.1111/j.1365-2036.2006.03191.x17229243
   PubMed Web of Science ®Google Scholar
• WoJM, EversmannJ, MannS. Pharmacokinetic profile of immediate-release omeprazole in patients with gastro-oesophageal reflux associated with gastroparesis. Aliment Pharmacol Ther. 2010;31(4):516–522. doi:10.1111/j.1365-2036.2009.04203.x19925497
   PubMed Web of Science ®Google Scholar
• Nexium (Esomeprazole magnesium) [package insert]. U.S. Food and Drug Administration, AstraZeneca Co.; November 2020. Available from: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021957. Accessed December 10, 2021.
   Google Scholar
• GardinerSJ, BeggEJ. Pharmacogenetics, drug-metabolizing enzymes, and clinical practice. Pharmacol Rev. 2006;58(3):521–590. doi:10.1124/pr.58.3.616968950
   PubMed Web of Science ®Google Scholar
• KimKN, YangSW, KimH, KwakSS, KimYS, ChoDY. 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. Clin Pharmacol Drug Dev. 2018;7(1):53–58. doi:10.1002/cpdd.33128111929
   PubMed Web of Science ®Google Scholar
• StrandDS, KimD, PeuraDA. 25 years of proton pump inhibitors: a comprehensive review. Gut Liver. 2017;11(1):27–37. doi:10.5009/gnl1550227840364
   PubMed Web of Science ®Google Scholar