{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T04:57:08Z","timestamp":1790744228298,"version":"4.1.0"},"reference-count":40,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T00:00:00Z","timestamp":1790640000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T00:00:00Z","timestamp":1790640000000},"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":[[2026,10]]},"abstract":"Abstract<\/jats:title>\n \n This single\u2010center, single\u2010arm, Phase I study evaluated drug\u2013drug interactions (DDIs) between cofrogliptin and metformin in healthy Chinese subjects. Twenty\u2010two subjects sequentially received metformin monotherapy (Days 1\u20134), cofrogliptin monotherapy (Days 6\u201334), and combination therapy (Days 38\u201347). Serial blood\/urine samples were collected for pharmacokinetic (PK) and pharmacodynamic (PD) analyses. Cofrogliptin showed no significant impact on metformin's PK and PD properties: the geometric mean ratios (GMRs, metformin + cofrogliptin\/metformin) with 90% confidence intervals (CIs) for metformin AUC\n 0\u20138\u00a0h<\/jats:sub>\n , AUC\n 0\u201312\u00a0h,<\/jats:sub>\n C\n SS (max)<\/jats:sub>\n , Ae\n 0\u20138\u00a0h<\/jats:sub>\n and Ratio\n 0\u20138\u00a0h<\/jats:sub>\n , were 0.872 (0.809, 0.941), 0.900 (0.834, 0.971), 0.840 (0.743, 0.950), 0.899 (0.782, 1.032), and 0.994 (0.871, 1.136), respectively; 90% CIs for plasma glucose AUEC\n 0\u20134\u00a0h<\/jats:sub>\n , AUEC\n 0\u20130.5\u00a0h<\/jats:sub>\n , and EC\n max<\/jats:sub>\n of combination (combination vs cofrogliptin monotherapy) all fell within 0.80\u20131.25. Metformin did not statistically affect cofrogliptin's PK and PD properties, as the GMRs (metformin + cofrogliptin\/cofrogliptin) (90% CIs) for cofrogliptin AUC over the dosing interval and C\n ss (max)<\/jats:sub>\n were 1.12 (1.072, 1.169) and 1.14 (1.057, 1.220), and AUEC\n 0\u2013168\u00a0h<\/jats:sub>\n , EC\n max<\/jats:sub>\n , and EC\n min<\/jats:sub>\n for dipeptidyl peptidase\u20104 inhibition rate were 1.01 (1.003, 1.015), 1.00 (1.001, 1.009), and 1.03 (1.005, 1.040), respectively. No deaths, serious adverse events, or severe hypoglycemia occurred. In conclusion, the combination of cofrogliptin and metformin had no clinically significant PK or PD DDIs in healthy Chinese subjects.\n <\/jats:p>","DOI":"10.1002\/cpdd.70092","type":"journal-article","created":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T04:16:55Z","timestamp":1790741815000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Pharmacokinetic and Pharmacodynamic Drug\u2010Drug Interactions Between Cofrogliptin and Metformin in Healthy Subjects: A Single\u2010Center, Single\u2010Arm, Phase I Study in China"],"prefix":"10.1002","volume":"15","author":[{"given":"Cheng","family":"Cui","sequence":"first","affiliation":[{"name":"Drug Clinical Trial Center, Department of Pharmacy Peking University Third Hospital Beijing China"},{"name":"Beijing Key Laboratory of Clinical Evaluation of Cardiovascular\u2010Kidney\u2010Metabolic and Immuno\u2010Inffammatory Innovative Drugs and Medical Devices Peking University Third Hospital Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Na","family":"Liu","sequence":"additional","affiliation":[{"name":"Clinical Research Center Beijing Haidian Hospital (Haidian Section of Peking University Third Hospital) Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chang","family":"Chu","sequence":"additional","affiliation":[{"name":"Haisco Pharmaceutical Group Co., Ltd Chengdu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shu","family":"Niu","sequence":"additional","affiliation":[{"name":"Drug Clinical Trial Center, Department of Pharmacy Peking University Third Hospital Beijing China"},{"name":"Department of Pharmaceuticals Outcome and Policy University of Florida FL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yang","family":"Huang","sequence":"additional","affiliation":[{"name":"Clinical Research Center Beijing Haidian Hospital (Haidian Section of Peking University Third Hospital) Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fangqiong","family":"Li","sequence":"additional","affiliation":[{"name":"Haisco Pharmaceutical Group Co., Ltd Chengdu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yaming","family":"Li","sequence":"additional","affiliation":[{"name":"Haisco Pharmaceutical Group Co., Ltd Chengdu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haiyan","family":"Li","sequence":"additional","affiliation":[{"name":"Drug Clinical Trial Center, Department of Pharmacy Peking University Third Hospital Beijing China"},{"name":"Beijing Key Laboratory of Clinical Evaluation of Cardiovascular\u2010Kidney\u2010Metabolic and Immuno\u2010Inffammatory Innovative Drugs and Medical Devices Peking University Third Hospital Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dongyang","family":"Liu","sequence":"additional","affiliation":[{"name":"Drug Clinical Trial Center, Department of Pharmacy Peking University Third Hospital Beijing China"},{"name":"Beijing Key Laboratory of Clinical Evaluation of Cardiovascular\u2010Kidney\u2010Metabolic and Immuno\u2010Inffammatory Innovative Drugs and Medical Devices Peking University Third Hospital Beijing China"},{"name":"Beijing Key Laboratory of Cardiovascular Receptors Research Peking University Third Hospital Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,29]]},"reference":[{"issue":"3","key":"e_1_2_11_2_1","doi-asserted-by":"crossref","DOI":"10.1016\/j.ijbiomac.2024.135422","article-title":"Effects of chitosan guanidine on blood glucose regulation and gut microbiota in T2DM","volume":"279","author":"Liu Y","year":"2024","journal-title":"Int J Biol 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