{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,22]],"date-time":"2026-01-22T05:47:54Z","timestamp":1769060874232,"version":"3.49.0"},"reference-count":26,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2017,6,6]],"date-time":"2017-06-06T00:00:00Z","timestamp":1496707200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Randlab Pty Ltd"}],"content-domain":{"domain":["beva.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Equine Veterinary Journal"],"published-print":{"date-parts":[[2017,11]]},"abstract":"Summary<\/jats:title>\n \n Reasons for performing the study<\/jats:title>\n Limited data are available on the relative pharmacokinetics and pharmacodynamics of different omeprazole formulations.<\/jats:p>\n <\/jats:sec>\n \n Objectives<\/jats:title>\n To compare pharmacokinetic and pharmacodynamic effects of a novel omeprazole formulation against a currently registered product.<\/jats:p>\n <\/jats:sec>\n \n Study design<\/jats:title>\n Masked 2 period, 2 treatment crossover.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n Twelve clinically healthy horses were studied over two 6\u2010day treatment periods. Horses were randomly assigned to receive a novel omeprazole paste (Ulcershield:\n ULS<\/jats:styled-content>\n ) or a currently registered reference omeprazole product (\n OMO<\/jats:styled-content>\n ). Gastric\n pH<\/jats:styled-content>\n was measured continuously for 10 h on the day prior to commencing treatment (Day \u20131) and after 6 days of oral treatment (Day 5) using\n in situ<\/jats:italic>\n antimony\n pH<\/jats:styled-content>\n probes within an indwelling nasogastric tube. Plasma pharmacokinetics were determined on Days 0 and 6.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Treatment significantly (P<0.005) increased gastric\n pH<\/jats:styled-content>\n on Day 5, compared to results obtained prior to treatment (Day \u20131) and there was no significant difference between products (P = 0.773). Similarly, comparison of median hourly gastric\n pH<\/jats:styled-content>\n (P = 0.593), mean gastric\n pH<\/jats:styled-content>\n (P = 0.154), percentage time pH<4 (P = 0.259) and area under the time\u2013gastric\n pH<\/jats:styled-content>\n response curve (P = 0.734) did not discriminate between products. Both treatments resulted in significantly lower gastric ulcer severity scores (both P = 0.004), with no difference between treatments (P = 0.688). Comparison of mean log area under time\u2013plasma concentration curves demonstrated that, although the lower limit of the 90% confidence interval was within the \u221220% limit for bioequivalence, the upper limit was exceeded, suggesting that the test product could have greater bioavailability than the reference product.\n <\/jats:p>\n <\/jats:sec>\n \n Main limitations<\/jats:title>\n The small sample size, large interhorse plasma omeprazole concentrations, and low bioavailability of omeprazole impacted the sensitivity of the bioequivalence analysis.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n ULS<\/jats:styled-content>\n matched or slightly exceeded\n OMO<\/jats:styled-content>\n plasma concentrations. Both products resulted in equivalent increases in gastric\n pH<\/jats:styled-content>\n , gastric\n pH<\/jats:styled-content>\n profiles and decrease in gastric ulcer scores. Thus,\n ULS<\/jats:styled-content>\n was pharmacodynamically equivalent to\n OMO<\/jats:styled-content>\n and was associated with an equivalent beneficial effect on gastric squamous mucosal ulceration.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/evj.12691","type":"journal-article","created":{"date-parts":[[2017,4,22]],"date-time":"2017-04-22T04:13:56Z","timestamp":1492834436000},"page":"802-809","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":23,"title":["Pharmacokinetic and pharmacodynamic effects of two omeprazole formulations on stomach\n pH<\/scp>\n and gastric ulcer scores"],"prefix":"10.1111","volume":"49","author":[{"given":"S. L.","family":"Raidal","sequence":"first","affiliation":[{"name":"School of Animal and Veterinary Sciences Veterinary Clinical Centre Charles Sturt University Wagga Wagga New South Wales Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7930-6237","authenticated-orcid":false,"given":"F. M.","family":"Andrews","sequence":"additional","affiliation":[{"name":"Equine Health Studies Program Department of Veterinary Clinical Sciences School of Veterinary Medicine Louisiana State University Baton Rouge Louisiana USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S. G.","family":"Nielsen","sequence":"additional","affiliation":[{"name":"School of Animal and Veterinary Sciences Veterinary Clinical Centre Charles Sturt University Wagga Wagga New South Wales Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"G.","family":"Trope","sequence":"additional","affiliation":[{"name":"School of Animal and Veterinary Sciences Veterinary Clinical Centre Charles Sturt University Wagga Wagga New South Wales Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,6,6]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/0005-2736(85)90064-1"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.2042-3306.1999.tb05176.x"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.2042-3306.1999.tb05171.x"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.2460\/ajvr.2000.61.784"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/jvim.13578"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.2460\/ajvr.2002.63.744"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.2460\/ajvr.2003.64.404"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.2460\/ajvr.2003.64.413"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.2460\/ajvr.67.11.1873"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.2042-3306.1999.tb05175.x"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/jvim.12341"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1097\/MEG.0b013e32834d4bac"},{"key":"e_1_2_12_14_1","unstructured":"Available fromhttp:\/\/www.fda.gov\/ucm\/groups\/fdagov-public\/@fdagov-av-gen\/documents\/document\/ucm415697.pdf"},{"key":"e_1_2_12_15_1","unstructured":"Available fromhttp:\/\/www.fda.gov\/downloads\/AnimalVeterinary\/GuidanceComplianceEnforcement\/GuidanceforIndustry\/ucm052363.pdf"},{"key":"e_1_2_12_16_1","unstructured":"Anon. 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