{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,25]],"date-time":"2026-01-25T13:58:21Z","timestamp":1769349501606,"version":"3.49.0"},"reference-count":34,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2026,1,19]],"date-time":"2026-01-19T00:00:00Z","timestamp":1768780800000},"content-version":"vor","delay-in-days":18,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,1,1]],"date-time":"2026-01-01T00:00:00Z","timestamp":1767225600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2026,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    This study assessed the effect of high\u2010fat food on pharmacokinetics and safety of amlodipine, benazepril, and benazeprilat in healthy Chinese participants under fasting and fed conditions from a bioequivalence trial. This trial enrolled a total of 92 healthy participants, and there was a significant difference in age between fasting and fed trials (\n                    <jats:italic>P<\/jats:italic>\n                    =\u00a0.006). These participants received an amlodipine\/benazepril capsule containing 5\u00a0mg amlodipine and 10\u00a0mg benazepril each period with a 21\u2010day washout under fasting or fed conditions. Twenty\u2010four blood samples were obtained from baseline to 168\u00a0h after drug administration for pharmacokinetic analyses. The plasma concentrations of amlodipine, benazepril, and benazeprilat were determined by a validated liquid chromatography\u2010tandem mass spectrometry method. After controlling for age, analysis of covariance (ANCOVA) or\n                    <jats:italic>Quade<\/jats:italic>\n                    \u2019s ANCOVA of pharmacokinetic results indicated that a high\u2010fat meal did not significantly influence the primary pharmacokinetic parameters of amlodipine, benazepril, and benazeprilat, except for the maximum plasma concentration (C\n                    <jats:sub>max<\/jats:sub>\n                    ) and time to reach maximum plasma concentration (T\n                    <jats:sub>max<\/jats:sub>\n                    ) for benazepril and benazeprilat. The high\u2010fat food decreased C\n                    <jats:sub>max<\/jats:sub>\n                    of benazepril by 64.1% and C\n                    <jats:sub>max<\/jats:sub>\n                    of benazeprilat by 30.8%, and increased T\n                    <jats:sub>max<\/jats:sub>\n                    of benazepril by 408.2% and T\n                    <jats:sub>max<\/jats:sub>\n                    of benazeprilat by 167.8% The incidence of most frequently observed AE of hypotension was significantly different (\n                    <jats:italic>P<\/jats:italic>\n                    =\u00a0.014, risk ratio = 2.286, and 95% confidence intervals 1.103 to 4.737) under fasting and fed conditions. It suggested that high\u2010fat food containing 800 to 1000\u00a0kcal might be the risk factor for healthy Chinese participants taking amlodipine\/benazepril capsules.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.70022","type":"journal-article","created":{"date-parts":[[2026,1,19]],"date-time":"2026-01-19T09:01:59Z","timestamp":1768813319000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Effect of High\u2010Fat Food on the Pharmacokinetics and Safety of Amlodipine\/Benazepril in Healthy Chinese Participants"],"prefix":"10.1002","volume":"15","author":[{"given":"Congyang","family":"Ding","sequence":"first","affiliation":[{"name":"Phase I Clinical Trial Laboratory Hebei General Hospital  Shijiazhuang Hebei China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Haojing","family":"Song","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trial Laboratory Hebei General Hospital  Shijiazhuang Hebei China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bo","family":"Qiu","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trial Laboratory Hebei General Hospital  Shijiazhuang Hebei China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xue","family":"Sun","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trial Laboratory Hebei General Hospital  Shijiazhuang Hebei China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Caihui","family":"Guo","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trial Laboratory Hebei General Hospital  Shijiazhuang Hebei China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wanjun","family":"Bai","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trial Laboratory Hebei General Hospital  Shijiazhuang Hebei China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Huizhen","family":"Wu","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trial Laboratory Hebei General Hospital  Shijiazhuang Hebei China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhanjun","family":"Dong","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trial Laboratory Hebei General Hospital  Shijiazhuang Hebei China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2026,1,19]]},"reference":[{"key":"e_1_2_10_2_1","volume-title":"Report on cardiovascular health and diseases in China 2022","year":"2023"},{"key":"e_1_2_10_3_1","unstructured":"Guideline for the Pharmacological Treatment of Hypertension in Adults. World Health Organization; 2021. Accessed January 12 2024.http:\/\/www.ncbi.nlm.nih.gov\/books\/NBK573631\/"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0806182"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-6175.2005.04615.x"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1161\/HYPERTENSIONAHA.109.130641"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(09)62100-0"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.2165\/11538850-000000000-00000"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjmed.2010.08.007"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.2147\/IBPC.S33985"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejps.2019.04.003"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF02570510"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1177\/0091270006291097"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.131"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.1064"},{"key":"e_1_2_10_16_1","unstructured":"U. S. Food and Drug Administration.Full Prescribing information of LOTREL (amlodipine and benazepril hydrochloride) capsules. April 21 2021. Accessed December 29 2023.https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/020364Orig1s068lbl.pdf"},{"key":"e_1_2_10_17_1","unstructured":"Health Canada. Benazepril product monograph. December 2 2019. Accessed March 26 2024.https:\/\/pdf.hres.ca\/dpd_pm\/00054195.PDF"},{"key":"e_1_2_10_18_1","unstructured":"Health Canada. Amlodipine product monograph. September 21 2023. Accessed March 26 2024.https:\/\/pdf.hres.ca\/dpd_pm\/00072734.PDF"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.curtheres.2005.04.005"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF01061471"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcla.23228"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.2147\/DDDT.S498337"},{"issue":"5","key":"e_1_2_10_23_1","first-page":"229","article-title":"The influence of food on the pharmacokinetics of amlodipine and losartan after single\u2010dose of its compound tablets in healthy Chinese subjects","volume":"64","author":"Lv C","year":"2014","journal-title":"Drug Res"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF00315579"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.1993.tb04217.x"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11095-008-9749-2"},{"key":"e_1_2_10_27_1","doi-asserted-by":"publisher","DOI":"10.1124\/jpet.108.143339"},{"key":"e_1_2_10_28_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10695-012-9649-6"},{"key":"e_1_2_10_29_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0026407"},{"key":"e_1_2_10_30_1","doi-asserted-by":"publisher","DOI":"10.1002\/clc.4960141807"},{"key":"e_1_2_10_31_1","doi-asserted-by":"publisher","DOI":"10.1080\/10717544.2019.1687613"},{"key":"e_1_2_10_32_1","unstructured":"U.S. Food and Drug Administration.Assessing the effects of food on drugs in INDs and NDAs \u2014 clinical pharmacology considerations. June 2022. Accessed November 26 2025.https:\/\/www.fda.gov\/media\/121313\/download"},{"key":"e_1_2_10_33_1","unstructured":"U.S. Food and Drug Administration.Generic drugs. March 13 2025. Accessed November 27 2025.https:\/\/www.fda.gov\/drugs\/buying\u2010using\u2010medicine\u2010safely\/generic\u2010drugs"},{"key":"e_1_2_10_34_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.e7586"},{"key":"e_1_2_10_35_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.943"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70022","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.70022","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70022","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,24]],"date-time":"2026-01-24T14:23:38Z","timestamp":1769264618000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.70022"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,1]]},"references-count":34,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2026,1]]}},"alternative-id":["10.1002\/cpdd.70022"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.70022","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,1]]},"assertion":[{"value":"2025-08-20","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-01-07","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-01-19","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70022"}}