Impact of Insulin Tregopil and its Permeation Enhancer on Pharmacokinetics of Metformin in Healthy Volunteers: Randomized, Open-label, Placebo Controlled, Crossover Study.

07:00 EST 28th December 2018 | BioPortfolio

Summary of "Impact of Insulin Tregopil and its Permeation Enhancer on Pharmacokinetics of Metformin in Healthy Volunteers: Randomized, Open-label, Placebo Controlled, Crossover Study."

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
ISSN: 1752-8062


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Medical and Biotech [MESH] Definitions

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