{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,24]],"date-time":"2026-03-24T14:33:35Z","timestamp":1774362815377,"version":"3.50.1"},"reference-count":12,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2025,11,14]],"date-time":"2025-11-14T00:00:00Z","timestamp":1763078400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,11,14]],"date-time":"2025-11-14T00:00:00Z","timestamp":1763078400000},"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":[[2026,3]]},"abstract":"Abstract<\/jats:title>\n \n This single\u2010center, randomized, open\u2010label bioequivalence program compared two fixed\u2010dose combination (FDC) tablets containing ibuprofen (200\u00a0mg) and phenylephrine hydrochloride (10\u00a0mg) from different manufacturers in healthy Chinese adults under fasting and fed conditions. A three\u2010period, partially replicated crossover design was used for the fasting study and a four\u2010period, fully replicated crossover design for the fed study. Serial plasma samples were collected up to 16\u00a0h post\u2010dose, and pharmacokinetic parameters included C\n max<\/jats:sub>\n , AUC\n 0\u2013t<\/jats:sub>\n , and AUC\n 0\u2013\u221e<\/jats:sub>\n for both analytes. Bioequivalence was assessed using average bioequivalence (ABE) when the within\u2010subject standard deviation of the reference was <0.294 and reference\u2010scaled ABE (RSABE) otherwise. The geometric mean ratios (90% CIs) for C\n max<\/jats:sub>\n , AUC\n 0\u2013t<\/jats:sub>\n , and AUC\n 0\u2013\u221e<\/jats:sub>\n of both ibuprofen and phenylephrine fell within 80%\u2013125% in both nutritional states, with RSABE applied to phenylephrine C\n max<\/jats:sub>\n where variability was high. Both products were well tolerated; adverse events were mild, comparable between test and reference, and no subject discontinued due to adverse events. These findings demonstrate bioequivalence of the two ibuprofen\/phenylephrine FDC and support their similar safety profiles in healthy Chinese volunteers.\n <\/jats:p>","DOI":"10.1002\/cpdd.1625","type":"journal-article","created":{"date-parts":[[2025,11,15]],"date-time":"2025-11-15T02:55:11Z","timestamp":1763175311000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Comparative Bioequivalence and Safety Evaluation of Ibuprofen\/Phenylephrine Hydrochloride Fixed\u2010Dose Combination Tablets in Healthy Chinese Volunteers"],"prefix":"10.1002","volume":"15","author":[{"given":"Menghan","family":"Ye","sequence":"first","affiliation":[{"name":"Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan People's Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rui","family":"Zhang","sequence":"additional","affiliation":[{"name":"Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan People's Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jing","family":"Wan","sequence":"additional","affiliation":[{"name":"Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan People's Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jinping","family":"Zhou","sequence":"additional","affiliation":[{"name":"Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan People's Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pengpeng","family":"Guo","sequence":"additional","affiliation":[{"name":"Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan People's Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dianwen","family":"Yu","sequence":"additional","affiliation":[{"name":"Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan People's Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peixia","family":"Li","sequence":"additional","affiliation":[{"name":"Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan People's Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yani","family":"Liu","sequence":"additional","affiliation":[{"name":"Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan People's Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shaojun","family":"Shi","sequence":"additional","affiliation":[{"name":"Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan People's Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,11,14]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj-2023-075306"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1208\/s12249-018-1271-1"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.5001\/omj.2010.49"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.2147\/JPR.S177967"},{"key":"e_1_2_11_6_1","volume-title":"StatPearls","author":"Richards E","year":"2023"},{"key":"e_1_2_11_7_1","unstructured":"Center for Disease Control (CDC) Public Health Law 2013. Pseudoephedrine: Legal Efforts to Make it a Prescription\u2010only Drug.https:\/\/www.cdc.gov\/phlp\/docs\/"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms22105146"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.yrtph.2018.04.008"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.2147\/DDDT.S404756"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13318-022-00766-9"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s41030-022-00206-8"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1208\/s12248-012-9406-x"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1625","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.1625","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1625","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,24]],"date-time":"2026-03-24T13:48:28Z","timestamp":1774360108000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.1625"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11,14]]},"references-count":12,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2026,3]]}},"alternative-id":["10.1002\/cpdd.1625"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.1625","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,11,14]]},"assertion":[{"value":"2025-09-02","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-10-22","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-11-14","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e1625"}}