A Clinical Trial for Analysis of Intestinal Microbiome Affecting PK, PD, and Safety of Metformin

Completed 20 enrolled Seoul National University Hospital

Non-randomizedSingle-groupOpen-labelBasic science

Summary

This clinical trial is intended to evaluate the effects of the changes in intestinal microbiome by antibiotics (PO vancomycin) on the pharmacokinetic /pharmacodynamic and safety profiles of metformin in healthy male volunteers.

Timeline

Start: 2018-12-01
Primary completion: 2019-02-28
Completion: 2019-02-28

Publications

Kim E, Kim AH, Lee Y, Ji SC, Cho JY, Yu KS, Chung JY. Effects of vancomycin-induced gut microbiome alteration on the pharmacodynamics of metformin in healthy male subjects. Clin Transl Sci. 2021 Sep;14(5):1955-1966. doi: 10.1111/cts.13051. Epub 2021 May 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metformin	Small molecule	1000 mg	Oral
Subject	Vancomycin	Other / unclassified	500 mg	Oral

Indications

No indication recorded.