{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T12:45:05Z","timestamp":1789994705754,"version":"4.0.1"},"reference-count":10,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2019,2,12]],"date-time":"2019-02-12T00:00:00Z","timestamp":1549929600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100007777","name":"Biocon","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007777","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2019,5]]},"abstract":"<jats:p>Oral insulin tregopil (<jats:styled-content style=\"fixed-case\">IN<\/jats:styled-content>\u2010105; a new drug under development) may be coadministered with oral antidiabetic drugs, such as metformin in patients with type 2 diabetes mellitus for optimal glycemic control. <jats:styled-content style=\"fixed-case\">IN<\/jats:styled-content>\u2010105 has sodium caprate excipient, a permeation enhancer, for enhancing absorption in the stomach and increasing bioavailability via an oral route. Sodium caprate may increase bioavailability of metformin by a similar mechanism. Therefore, it was necessary to study the effect of <jats:styled-content style=\"fixed-case\">IN<\/jats:styled-content>\u2010105 on pharmacokinetics (PKs) of metformin. In this randomized, open\u2010label, cross\u2010over study, metformin was administered to healthy volunteers receiving <jats:styled-content style=\"fixed-case\">IN<\/jats:styled-content>\u2010105\/placebo under fed\/fasting conditions. The 90% confidence interval (<jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>) of the geometric mean ratio of the area under the curve from time zero to infinity (<jats:styled-content style=\"fixed-case\">AUC<\/jats:styled-content><jats:sub>0\u2010inf<\/jats:sub>; fasting and fed) and peak plasma concentration (C<jats:sub>max<\/jats:sub>; fed) of metformin were within 0.80\u20131.25 acceptance range. Under fasting conditions, the upper bound margin of C<jats:sub>max<\/jats:sub> was just beyond this range (i.e., 1.27) and was concluded as functionally not relevant. There was no clinically significant effect of sodium caprate\/<jats:styled-content style=\"fixed-case\">IN<\/jats:styled-content>\u2010105 on PKs of metformin under fasting\/fed conditions, and it was safe.<\/jats:p>","DOI":"10.1111\/cts.12609","type":"journal-article","created":{"date-parts":[[2018,12,28]],"date-time":"2018-12-28T15:25:09Z","timestamp":1546010709000},"page":"276-282","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":29,"title":["Impact of Insulin Tregopil and Its Permeation Enhancer on Pharmacokinetics of Metformin in Healthy Volunteers: Randomized, Open\u2010Label, Placebo\u2010Controlled, Crossover Study"],"prefix":"10.1111","volume":"12","author":[{"given":"Anand","family":"Khedkar","sequence":"first","affiliation":[{"name":"Biocon Research Ltd.,  Bengaluru Karnataka India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harold","family":"Lebovitz","sequence":"additional","affiliation":[{"name":"State University of New York Health Science Center at Brooklyn  Brooklyn New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Fleming","sequence":"additional","affiliation":[{"name":"Kinexum  Harpers Ferry West Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alan","family":"Cherrington","sequence":"additional","affiliation":[{"name":"Vanderbilt University School of Medicine  Nashville Tennessee USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vinu","family":"Jose","sequence":"additional","affiliation":[{"name":"Biocon Research Ltd.,  Bengaluru Karnataka India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandeep N.","family":"Athalye","sequence":"additional","affiliation":[{"name":"Biocon Research Ltd.,  Bengaluru Karnataka India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashwini","family":"Vishweswaramurthy","sequence":"additional","affiliation":[{"name":"Biocon Research Ltd.,  Bengaluru Karnataka India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,2,12]]},"reference":[{"key":"e_1_2_11_1_1","doi-asserted-by":"publisher","DOI":"10.1177\/1932296817691303"},{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1463-1326.2010.01213.x"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.2147\/PPA.S10178"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1023\/A:1018909210879"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1124\/jpet.114.220350"},{"key":"e_1_2_11_6_1","unstructured":"Serono M.Glucophage 500\u00a0mg and 850\u00a0mg Film Coated Tablets \u2013 Summary of Product Characteristics (SPC) \u2013 Electronic Medicines Compendium (eMC). 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