{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,25]],"date-time":"2026-07-25T05:02:54Z","timestamp":1784955774000,"version":"3.55.0"},"reference-count":20,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2026,7,20]],"date-time":"2026-07-20T00:00:00Z","timestamp":1784505600000},"content-version":"vor","delay-in-days":19,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T00:00:00Z","timestamp":1782864000000},"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":[[2026,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Levodopa and benserazide tablets (LBTs) are a combined preparation of levodopa (L\u2010DP), a dopamine precursor, and benserazide (BZ), a peripheral dopa decarboxylase inhibitor, used for the treatment of Parkinson's disease, which predominantly affects middle\u2010aged and elderly individuals. This study employed a single\u2010center, randomized, open\u2010label, two\u2010formulation, three\u2010period, three\u2010sequence, partially replicated (reference formulation only) clinical study design to evaluate the pharmacokinetics and bioequivalence of the test and reference formulations of LBT administered orally to 96 healthy Chinese subjects under fasting or fed conditions. After fasting for at least 10 h and abstaining from water for 1 h, subjects received one tablet of either the test or reference formulation with 240\u00a0mL of warm water on Days 1, 8, and 15 of the study, either in the fasting state or 30 min after starting a high\u2010fat meal. Plasma drug concentrations were determined using an ultra\u2010high performance liquid chromatography\u2010tandem mass spectrometry method. The 90% confidence intervals of the geometric mean ratios for the pharmacokinetic parameters 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                    met the bioequivalence criteria, indicating that the test formulation is bioequivalent to the reference formulation in healthy Chinese adult subjects. No serious adverse events were reported.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.70080","type":"journal-article","created":{"date-parts":[[2026,7,20]],"date-time":"2026-07-20T13:27:58Z","timestamp":1784554078000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Pharmacokinetics and Bioequivalence Study of Levodopa and Benserazide Tablets in Healthy Chinese Subjects Under Fasting and High\u2010Fat Meal Conditions"],"prefix":"10.1002","volume":"15","author":[{"given":"Yufei","family":"Liang","sequence":"first","affiliation":[{"name":"Phase I Clinical Trials Center Hebei PetroChina Central Hospital  Langfang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanchao","family":"Wang","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trials Center Hebei PetroChina Central Hospital  Langfang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rui","family":"Shi","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trials Center Hebei PetroChina Central Hospital  Langfang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yingzi","family":"Pei","sequence":"additional","affiliation":[{"name":"Department of Clinical Research Beijing Foyou Pharmaceutical Co., Ltd.  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiao","family":"Zhao","sequence":"additional","affiliation":[{"name":"Department of Clinical Research Beijing Foyou Pharmaceutical Co., Ltd.  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qian","family":"Wang","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trials Center Hebei PetroChina Central Hospital  Langfang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanping","family":"Ren","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trials Center Hebei PetroChina Central Hospital  Langfang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zekang","family":"Xie","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trials Center Hebei PetroChina Central Hospital  Langfang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kexin","family":"Zhao","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trials Center Hebei PetroChina Central Hospital  Langfang China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,20]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjmed.2019.03.001"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00702-025-02893-4"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0031610"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/WNF.0b013e31825645d1"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2011.04.012"},{"key":"e_1_2_9_7_1","volume-title":"Statistical Approaches to Establishing Bioequivalence: Guidance for Industry","author":"US Food and Drug Administration","year":"2001"},{"key":"e_1_2_9_8_1","volume-title":"Guideline on the Investigation of Bioequivalence (Rev 1)","author":"European Medicines Agency","year":"2010"},{"key":"e_1_2_9_9_1","volume-title":"Technical Guideline for Bioequivalence Studies of Highly Variable Drugs","author":"China National Medical Products Administration","year":"2018"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2125.1997.00610.x"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1159\/000067025"},{"key":"e_1_2_9_12_1","volume-title":"Levodopa and benserazide tablets. Package insert","year":"2023"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.2174\/138920021705160324170558"},{"key":"e_1_2_9_14_1","volume-title":"21 CFR Part 320: Bioavailability and Bioequivalence Requirements","author":"US Food and Drug Administration","year":"2024"},{"key":"e_1_2_9_15_1","unstructured":"European Medicines Agency.Guideline on Clinical Development of Fixed Combination Medicinal Products (Revision 2). EMA\/CHMP\/158268\/2017;2017."},{"key":"e_1_2_9_16_1","volume-title":"Technical Guideline for Bioequivalence Studies Using Pharmacokinetic Endpoints","author":"China National Medical Products Administration","year":"2021"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.14086"},{"key":"e_1_2_9_18_1","volume-title":"Technical Guidelines for Bioequivalence Studies of Generic Chemical Drugs in Humans Using Pharmacokinetic Endpoints","author":"China National Medical Products Administration","year":"2016"},{"key":"e_1_2_9_19_1","volume-title":"Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA. 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