{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T00:55:50Z","timestamp":1788742550614,"version":"build-2803163510"},"reference-count":25,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2019,2,27]],"date-time":"2019-02-27T00:00:00Z","timestamp":1551225600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["2017ZX09304\u2010021"],"award-info":[{"award-number":["2017ZX09304\u2010021"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2019,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Chiglitazar (CHI) is a potent and selective peroxisome proliferator\u2010activated receptor potentially for the treatment of patients with type 2 diabetes mellitus (T2DM). An open\u2010label, randomized, 3\u2010period crossover and self\u2010controlled study was conducted to investigate drug\u2010drug interaction potential between CHI and metformin hydrochloride (MET). Eligible subjects received a single oral dose of CHI (48 mg), MET (1000 mg), or a combination in each period, followed by serial blood sampling collected for up to 48\u00a0hours postdose, and safety was assessed throughout the trial. The area under the plasma concentration\u2010time curves from time 0 to 48\u00a0hours (AUC<jats:sub>0\u201048\u00a0h<\/jats:sub>) of CHI was similar following administration alone or with MET (AUC<jats:sub>0\u201048h<\/jats:sub>, 12\u00a0540 ng\u00b7h\/mL [9811\u201015\u00a0269 ng\u00b7h\/mL] vs 12\u00a0130 ng\u00b7h\/mL [9304\u201014\u00a0956 ng\u00b7h\/mL]; 90% confidence interval [CI] of its geometric mean ratio [GMR], 89.7%\u2013103.8%), whereas the maximum concentration (C<jats:sub>max<\/jats:sub>) of CHI was reduced during coadministration, as its 90%CI of the GMR was slightly outside the acceptance range for bioequivalence (C<jats:sub>max<\/jats:sub>, 1620 ng\/mL [1418\u20101822 ng\/mL] vs 1420 ng\/mL [1049\u20101791 ng\/mL], 90%CI GMR, 77.%\u201094.1%). However, it was not considered clinically meaningful. The MET exposures remained consistent in the absence or presence of CHI (AUC<jats:sub>0\u201048\u00a0h<\/jats:sub>, 12\u00a0570 ng\u00b7h\/mL [10681\u201014\u00a0459 ng\u00b7h\/mL] vs 13\u00a0190 [10973\u201015\u00a0407 ng\u00b7h\/mL); 90%CI of GMR: 99.1%\u2010110.5%; C<jats:sub>max<\/jats:sub>, 1790 ng\/mL [1448\u20132132 ng\/mL] vs 1820 ng\/mL [1510\u20102130 ng\/mL]; 90%CI of GMR, 94.2%\u2013110.9%). No moderate to severe adverse events were reported. Our study indicated no clinically significant pharmacokinetic drug\u2010drug interaction between CHI and MET and demonstrated good tolerance in subjects. These results support future application of CHI in combination with MET for treatment of T2DM.<\/jats:p>","DOI":"10.1002\/cpdd.668","type":"journal-article","created":{"date-parts":[[2019,2,27]],"date-time":"2019-02-27T08:14:11Z","timestamp":1551255251000},"page":"934-941","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Study on Drug\u2010Drug Interactions Between Chiglitazar, a Novel PPAR Pan\u2010Agonist, and Metformin Hydrochloride in Healthy Subjects"],"prefix":"10.1002","volume":"8","author":[{"given":"Ling","family":"Yi","sequence":"first","affiliation":[{"name":"Drug Clinical Trials Institution The First Affiliated Hospital of Soochow University  Suzhou City Jiangsu Province P.R.China"},{"name":"Laboratory of Phase I Clinical Study The First Affiliated Hospital of Soochow University  Suzhou City Jiangsu Province P.R.China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hua","family":"Zhang","sequence":"additional","affiliation":[{"name":"Drug Clinical Trials Institution The First Affiliated Hospital of Soochow University  Suzhou City Jiangsu Province P.R.China"},{"name":"Laboratory of Phase I Clinical Study The First Affiliated Hospital of Soochow University  Suzhou City Jiangsu Province P.R.China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jin\u2010wen","family":"Zhang","sequence":"additional","affiliation":[{"name":"Exploratory Research Department Shenzhen Chipscreen Biosciences Ltd. BIO\u2010Incubator Shenzhen Hi\u2010Tech Industrial Park  Guangdong Shenzhen China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiao\u2010ming","family":"You","sequence":"additional","affiliation":[{"name":"Drug Clinical Trials Institution The First Affiliated Hospital of Soochow University  Suzhou City Jiangsu Province P.R.China"},{"name":"Laboratory of Phase I Clinical Study The First Affiliated Hospital of Soochow University  Suzhou City Jiangsu Province P.R.China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhi\u2010qiang","family":"Ning","sequence":"additional","affiliation":[{"name":"Exploratory Research Department Shenzhen Chipscreen Biosciences Ltd. BIO\u2010Incubator Shenzhen Hi\u2010Tech Industrial Park  Guangdong Shenzhen China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jia","family":"Yu","sequence":"additional","affiliation":[{"name":"Exploratory Research Department Shenzhen Chipscreen Biosciences Ltd. 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