{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,25]],"date-time":"2026-01-25T13:56:35Z","timestamp":1769349395696,"version":"3.49.0"},"reference-count":23,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2025,7,3]],"date-time":"2025-07-03T00:00:00Z","timestamp":1751500800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2025,7,3]],"date-time":"2025-07-03T00:00:00Z","timestamp":1751500800000},"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                    Aildenafil citrate is a novel and potent phosphodiesterase type 5 inhibitor for the treatment of erectile dysfunction (ED). This study evaluates the pharmacokinetics and bioequivalence of 2 formulations of aildenafil citrate tablets (30 and 60\u00a0mg) in healthy Chinese male subjects under both fasting and fed conditions. A single\u2010center, randomized, open\u2010label, 2\u2010period crossover design was employed, with 78 participants enrolled, including 30 in the fasting condition and 48 in the fed condition. Blood samples were collected at multiple time points for pharmacokinetic analysis, which included C\n                    <jats:sub>max<\/jats:sub>\n                    , AUC\n                    <jats:sub>0\u2010t<\/jats:sub>\n                    , and AUC\n                    <jats:sub>0\u2010\u221e<\/jats:sub>\n                    as the primary parameters. The results demonstrated that the pharmacokinetic profiles of the test and reference formulations were comparable in both the fasting and fed states, with 90% confidence intervals for the geometric mean ratios of C\n                    <jats:sub>max<\/jats:sub>\n                    , AUC\n                    <jats:sub>0\u2010t<\/jats:sub>\n                    , and AUC\n                    <jats:sub>0\u2010\u221e<\/jats:sub>\n                    falling within the 80%\u2010125% range, confirming bioequivalence. Although food intake slightly delayed the time to peak concentration and reduced the absorption rate, it did not significantly affect the overall bioavailability. Both formulations were well tolerated, with adverse events being mild and resolving spontaneously. This study provides evidence supporting the bioequivalence of the 2 aildenafil citrate formulations and their interchangeability for clinical use in treating ED.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.1571","type":"journal-article","created":{"date-parts":[[2025,7,3]],"date-time":"2025-07-03T09:59:13Z","timestamp":1751536753000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Pharmacokinetics and Bioequivalence Evaluation of Two Different Aildenafil Citrate Tablet Formulations in Healthy Chinese Male Subjects Under Fasting and Fed Conditions"],"prefix":"10.1002","volume":"15","author":[{"given":"Hegui","family":"Yan","sequence":"first","affiliation":[{"name":"Phase I Clinical Research Center Wuhan Pulmonary Hospital Wuhan Institute of Tuberculosis Prevention and Control  Wuhan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yu","family":"Peng","sequence":"additional","affiliation":[{"name":"Phase I Clinical Research Center Wuhan Pulmonary Hospital Wuhan Institute of Tuberculosis Prevention and Control  Wuhan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhixiang","family":"Pan","sequence":"additional","affiliation":[{"name":"Phase I Clinical Research Center Wuhan Pulmonary Hospital Wuhan Institute of Tuberculosis Prevention and Control  Wuhan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yiyi","family":"Wang","sequence":"additional","affiliation":[{"name":"Phase I Clinical Research Center Wuhan Pulmonary Hospital Wuhan Institute of Tuberculosis Prevention and Control  Wuhan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Quan","family":"Li","sequence":"additional","affiliation":[{"name":"Phase I Clinical Research Center Wuhan Pulmonary Hospital Wuhan Institute of Tuberculosis Prevention and Control  Wuhan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Guan","family":"Liu","sequence":"additional","affiliation":[{"name":"Phase I Clinical Research Center Wuhan Pulmonary Hospital Wuhan Institute of Tuberculosis Prevention and Control  Wuhan China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,7,3]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jsxm.2015.12.019"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1464-410x.1999.00142.x"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.5534\/wjmh.230145"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1743-6109.2010.01778.x"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1038\/aja.2010.127"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.12688\/f1000research.16576.1"},{"key":"e_1_2_10_8_1","volume-title":"Erectile Dysfunction","author":"Leslie SW","year":"2024"},{"issue":"4","key":"e_1_2_10_9_1","article-title":"Utilization trends of phosphodiesterase type\u20105 inhibitors for erectile dysfunction between 2019 and 2023 in Tanzania","volume":"16","author":"Sangeda 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ZJ","year":"2006","journal-title":"Natl J Androly"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/dta.1564"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.21037\/tau-21-441"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2007.01.017"},{"key":"e_1_2_10_20_1","unstructured":"National Medical Products Administration (NMPA).Technical guidelines for the study of human bioequivalence of generic chemical drugs with pharmacokinetic metrics as endpoint evaluation index.2016."},{"key":"e_1_2_10_21_1","unstructured":"Food and Drug Administration (FDA).Bioequvalence studies with pharmacokinetic endpoints for drugs submitted under an ANDA guidance for industry.2021."},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11255-017-1644-5"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1111\/iju.14785"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.urology.2009.04.026"}],"container-title":["Clinical Pharmacology in Drug 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