{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T13:19:23Z","timestamp":1787750363255,"version":"build-2784847793"},"reference-count":9,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"4","license":[{"start":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T00:00:00Z","timestamp":1782864000000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2026,7]]},"abstract":"Abstract:<\/jats:title>\n \n OBJECTIVE:<\/jats:title>\n The purpose of this study was to compare the Pharmacokinetics of Sitagliptin 100 mg tablets in healthy Asian Indian and Thai Volunteers.<\/jats:p>\n <\/jats:sec>\n \n MATERIALS AND METHODS:<\/jats:title>\n \n Two independent crossover evaluations were conducted in healthy adults of Indian (Study 1) and Thai (Study 2) origin. Participants received a single 100 mg dose of either test or reference sitagliptin tablet under fasting conditions, followed by the alternate product after a washout. Plasma sitagliptin was quantified by validated LC-MS\/MS, and non-compartmental analysis yielded Cmax, AUC\n 0\u2013t<\/jats:sub>\n , AUC\n 0\u2013\u221e<\/jats:sub>\n , and T\n max.<\/jats:sub>\n Bioequivalence was concluded when 90% confidence intervals (CIs) for geometric mean ratios fell within 80%\u2013125%.\n <\/jats:p>\n <\/jats:sec>\n \n RESULTS:<\/jats:title>\n \n For both Indian and Thai cohorts, point estimates and 90% CIs for Cmax, AUC\n 0\u2013t<\/jats:sub>\n and AUC\n 0\u2013\u221e<\/jats:sub>\n were contained in predefined 80%\u2013125% interval, and no clinically meaningful differences between formulations were detected. Exposure metrics were comparable across the two ethnic groups.\n <\/jats:p>\n <\/jats:sec>\n \n CONCLUSIONS:<\/jats:title>\n \n In the two studies conducted in healthy Asian Indian and Thai volunteers, the test and reference formulation of sitagliptin 100 mg exhibited comparable pharmacokinetics profiles and were bioequivalent according to the regulatory definition based on rate and extent of absorption. Both formulations were well tolerated by all volunteers. Similar C\n max<\/jats:sub>\n and AUC values were observed across both populations, indicating that ethnicity has no significant effect on the pharmacokinetics of sitagliptin. Therefore, bioequivalence results obtained in one population can be extrapolated to others.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.4103\/ijp.ijp_44_26","type":"journal-article","created":{"date-parts":[[2026,6,25]],"date-time":"2026-06-25T18:00:16Z","timestamp":1782410416000},"page":"452-456","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":0,"title":["Comparison of pharmacokinetics of sitagliptin 100 mg tablets in healthy Asian Indian and Thai volunteers"],"prefix":"10.4103","volume":"58","author":[{"given":"Anurag","family":"Saro","sequence":"first","affiliation":[{"name":"Clinical Pharmacology and Pharmacokinetics Sun Pharmaceutical Industries Limited, Gurugram, Haryana, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arshad H.","family":"Khuroo","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Pharmacokinetics Sun Pharmaceutical Industries Limited, Gurugram, Haryana, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sudershan","family":"Kumar","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Pharmacokinetics Sun Pharmaceutical Industries Limited, Gurugram, Haryana, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sovan","family":"Maiti","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Pharmacokinetics Sun Pharmaceutical Industries Limited, Gurugram, Haryana, India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2026,7,1]]},"reference":[{"key":"R1-20260626","doi-asserted-by":"crossref","first-page":"1613","DOI":"10.1517\/14656566.2011.580738","article-title":"Sitagliptin: A review","volume":"12","author":"Subbarayan","year":"2011","journal-title":"Expert Opin Pharmacother"},{"key":"R2-20260626","doi-asserted-by":"crossref","first-page":"209","DOI":"10.1007\/s40265-016-0686-9","article-title":"Sitagliptin: A review in type 2 diabetes","volume":"77","author":"Scott","year":"2017","journal-title":"Drugs"},{"key":"R3-20260626","doi-asserted-by":"crossref","first-page":"489","DOI":"10.2165\/11203790-000000000-00000","article-title":"Sitagliptin: A review of its use in the management of type 2 diabetes mellitus","volume":"70","author":"Dhillon","year":"2010","journal-title":"Drugs"},{"key":"R4-20260626","doi-asserted-by":"crossref","first-page":"223","DOI":"10.1007\/s40265-013-0169-1","article-title":"Sitagliptin: A review of its use in patients with type 2 diabetes mellitus","volume":"74","author":"Plosker","year":"2014","journal-title":"Drugs"},{"key":"R5-20260626","doi-asserted-by":"crossref","first-page":"587","DOI":"10.2165\/00003495-200767040-00007","article-title":"Sitagliptin","volume":"67","author":"Lyseng-Williamson","year":"2007","journal-title":"Drugs"},{"key":"R9-20260626","doi-asserted-by":"crossref","first-page":"307","DOI":"10.1002\/bdd.559","article-title":"Dose-proportionality of a final market image sitagliptin formulation, an oral dipeptidyl peptidase-4 inhibitor, in healthy volunteers","volume":"28","author":"Bergman","year":"2007","journal-title":"Biopharm Drug Dispos"},{"key":"R10-20260626","doi-asserted-by":"crossref","first-page":"315","DOI":"10.1002\/bdd.560","article-title":"Absolute bioavailability of sitagliptin, an oral dipeptidyl peptidase-4 inhibitor, in healthy volunteers","volume":"28","author":"Bergman","year":"2007","journal-title":"Biopharm Drug Dispos"},{"key":"R11-20260626","doi-asserted-by":"crossref","first-page":"525","DOI":"10.1124\/dmd.106.013110","article-title":"Disposition of the dipeptidyl peptidase 4 inhibitor sitagliptin in rats and dogs","volume":"35","author":"Beconi","year":"2007","journal-title":"Drug Metab Dispos"},{"key":"R12-20260626","doi-asserted-by":"crossref","first-page":"533","DOI":"10.1124\/dmd.106.013136","article-title":"Metabolism and excretion of the dipeptidyl peptidase 4 inhibitor [14C] sitagliptin in humans","volume":"35","author":"Vincent","year":"2007","journal-title":"Drug Metab Dispos"}],"container-title":["Indian Journal of Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ovid.com\/10.4103\/ijp.ijp_44_26","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T12:27:20Z","timestamp":1787747240000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ovid.com\/10.4103\/ijp.ijp_44_26"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7]]},"references-count":9,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2026]]}},"URL":"https:\/\/doi.org\/10.4103\/ijp.ijp_44_26","relation":{},"ISSN":["0253-7613","1998-3751"],"issn-type":[{"value":"0253-7613","type":"print"},{"value":"1998-3751","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7]]},"assertion":[{"value":"2026-01-09","name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-03-03","name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}}]}}