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Oral insulin tregopil (IN-105; new drug under development) may be co-administered with oral anti-diabetic drugs such as metformin in type 2 diabetes mellitus patients for optimal glycemic control. IN-105 has sodium caprate excipient, a permeation enhancer, for enhancing absorption in stomach and increasing bioavailability via oral route. Sodium caprate may increase bioavailability of metformin by a similar mechanism. Therefore, it was necessary to study effect of IN-105 on pharmacokinetics of metformin. In this randomized, open-label, cross-over study, metformin was administered to healthy volunteers receiving IN-105/placebo under fed/fasting conditions. 90% CI of GMR of AUC (fasting and fed) and C (fed) of metformin were within 0.80-1.25. Under fasting conditions, upper bound margin of C 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/IN-105 on pharmacokinetics of metformin under fasting/fed conditions and it was safe. This article is protected by copyright. All rights reserved.
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Name: Clinical and translational science
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A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289)
A pharmaceutical preparation of sitagliptin phosphate and metformin hydrochloride that is used in the treatment of TYPE 2 DIABETES.
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