{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2023,11,2]],"date-time":"2023-11-02T06:40:33Z","timestamp":1698907233210},"reference-count":19,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2023,10,10]],"date-time":"2023-10-10T00:00:00Z","timestamp":1696896000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2023,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Allisartan isoproxil (AI) is an angiotensin II type 1 receptor blocker and be converted into the active substance EXP3174 in vivo. We evaluated the drug\u2013drug interactions of AI and an indapamide sustained\u2010release (Ind SR) preparation, as well as the pharmacokinetic characteristics and safety of AI and Ind SR in healthy subjects. The trial was set up in 6 sequences and 3 cycles, and each cycle contained a 7\u2010day washout period. Subjects received 3 different trial drugs (A, AI; B, Ind SR; C, AI\u00a0+\u00a0Ind SR) during 3 different cycles. Twenty\u2010four subjects were enrolled in the clinical trial. Of these, 22 completed the study, 2 subjects dropped out due to adverse events (AEs). For subjects given AI alone or combined with Ind SR, the pharmacogenetic parameters C<jats:sub>max<\/jats:sub> and the geometric mean ratio of steady state (combined\/single) of EXP3174 was 130%. The geometric mean ratio of area under the concentration\u2013time curve over the dosing interval at steady state (combined\/single use) was 144.5%. Therefore, the combination of Ind SR had an impact on the pharmacokinetics of AI. Then, the results indicated that the AI combination had no effect on the pharmacokinetics of Ind SR. Serious AEs did not occur. The AEs in this clinical trial were the same as those for AI and Ind SR. Combined administration resulted in 2 cases (2 subjects) of Grade 3 hypotension and 1 case of Grade 3 hypotension with AI alone. Considering that this trial included healthy volunteers, the risk of hypotension was expected to be manageable.<\/jats:p>","DOI":"10.1002\/cpdd.1321","type":"journal-article","created":{"date-parts":[[2023,10,11]],"date-time":"2023-10-11T23:27:14Z","timestamp":1697066834000},"page":"1051-1059","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Pharmacokinetics and Drug\u2013Drug Interaction of Allisartan Isoproxil and Indapamide Sustained\u2010Release Formulation"],"prefix":"10.1002","volume":"12","author":[{"given":"Wu","family":"Yi","sequence":"first","affiliation":[{"name":"Department of Clinical Medicine Medical College of Soochow University  Suzhou China"},{"name":"Center for Clinical Pharmacy, Cancer Center, Clinical Research Institute, Zhejiang Provincial People's Hospital (Affiliated People's Hospital) Hangzhou Medical College  Hangzhou Zhejiang 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