{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T02:03:25Z","timestamp":1789351405952,"version":"build-2803163510"},"reference-count":32,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,9,13]],"date-time":"2026-09-13T00:00:00Z","timestamp":1789257600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,9,13]],"date-time":"2026-09-13T00:00:00Z","timestamp":1789257600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"abstract":"\n Aims<\/jats:title>\n Aildenafil citrate, an orally bioavailable phosphodiesterase type 5 (PDE5) inhibitor, is primarily metabolized by cytochrome P450 3A4 (CYP3A4). This study aimed to assess potential pharmacokinetic interactions between aildenafil citrate tablets and cytochrome P450 (CYP)3A modulators.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n This study involved three open\u2010label, fixed\u2010sequence trials in healthy subjects. Participants received a single oral dose of aildenafil 60\u2009mg alone and with repeated doses of clarithromycin (500\u2009mg, CYP3A4 inhibitor,\n N<\/jats:italic>\n \u2009=\u200918), rifampin (600\u2009mg, inducer,\n N<\/jats:italic>\n \u2009=\u200918), or cimetidine (400\u2009mg,\n N<\/jats:italic>\n \u2009=\u200918). Pharmacokinetic (PK) parameters\u2014including maximum serum concentration (\n C<\/jats:italic>\n \u2098\u2090\u2093), area under the concentration\u2010time curve (AUC), time to reach\n C<\/jats:italic>\n \u2098\u2090\u2093, and half\u2010life (\n t<\/jats:italic>\n 1\/2<\/jats:sub>\n )\u2014were calculated using noncompartmental analysis from serial serum aildenafil concentrations. Adverse events were monitored throughout.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Clarithromycin significantly increased aildenafil exposure, with geometric mean ratios (90% CI) of 1.67 (1.51\u20131.85) for\n C<\/jats:italic>\n max<\/jats:sub>\n and 2.58 (2.42\u20132.76) for\n AUC<\/jats:italic>\n 0\u2212\u221e<\/jats:sub>\n . Conversely, rifampin markedly reduced aildenafil serum concentrations, with geometric mean ratios (90% CI) of 0.02 (0.02\u20130.03) for\n C<\/jats:italic>\n max<\/jats:sub>\n and 0.01 (0.01\u20130.02) for\n AUC<\/jats:italic>\n 0\u2212\u221e<\/jats:sub>\n . Coadministration with cimetidine resulted in log\u2010transformed\n C<\/jats:italic>\n max<\/jats:sub>\n and\n AUC<\/jats:italic>\n 0\u2212\u221e<\/jats:sub>\n ratios near 1.0 (0.99 and 1.17, respectively), with geometric mean ratios (90% CI) of 0.99 (0.84\u20131.16) and 1.17 (1.10\u20131.25), indicating no significant effect on aildenafil exposure.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n Coadministration of aildenafil with the strong CYP3A4 inhibitor clarithromycin increased aildenafil\n AUC<\/jats:italic>\n 0\u2212\u221e<\/jats:sub>\n by 2.58\u2010fold and\n C<\/jats:italic>\n max<\/jats:sub>\n by 1.67\u2010fold; therefore, dose adjustment should be guided by clinical response and tolerability. In contrast, coadministration with the strong CYP3A4 inducer rifampin is not recommended.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1002\/bcp.70781","type":"journal-article","created":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T01:34:36Z","timestamp":1789349676000},"source":"Crossref","is-referenced-by-count":0,"title":["Pharmacokinetic and safety interactions between aildenafil and clarithromycin, cimetidine, or rifampin in healthy subjects"],"prefix":"10.1002","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7897-517X","authenticated-orcid":false,"given":"Ran","family":"Xie","sequence":"first","affiliation":[{"name":"Drug Clinical Trial institution Peking University First Hospital Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nan","family":"Zhao","sequence":"additional","affiliation":[{"name":"Drug Clinical Trial institution Peking University First Hospital Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bo","family":"Jia","sequence":"additional","affiliation":[{"name":"Drug Clinical Trial institution Peking University First Hospital Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lu","family":"Cheng","sequence":"additional","affiliation":[{"name":"Drug Clinical Trial institution Peking University First Hospital Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junyu","family":"Xu","sequence":"additional","affiliation":[{"name":"Drug Clinical Trial institution Peking University First Hospital Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xia","family":"Wang","sequence":"additional","affiliation":[{"name":"Research and Development Center Youcare Pharmaceutical Group Co., Ltd. Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2497-3934","authenticated-orcid":false,"given":"Xia","family":"Zhao","sequence":"additional","affiliation":[{"name":"Drug Clinical Trial institution Peking University First Hospital Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4186-1005","authenticated-orcid":false,"given":"Yimin","family":"Cui","sequence":"additional","affiliation":[{"name":"Institute of Clinical Pharmacology Peking University First Hospital Beijing China"},{"name":"Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences Peking University Beijing China"},{"name":"Beijing Key Laboratory of Clinical Pharmacology and Translation of Innovative Drugs Beijing 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