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

NCT03809260 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-10-08

No results posted yet for this study

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.

Conditions

  • Human Microbiome

Interventions

DRUG

Metformin (part 1)

1\~4d: Metformin 1000 mg bid (Except for 500 mg after 1d lunch), 16d\~19d: Metformin 1000 mg bid (Except for 500 mg after 16d lunch).

DRUG

Vancomycin

11d: Vancomycin 250 mg bid, 12\~17d: Vancomycin 500 mg bid

DRUG

Metformin (part 2)

1\~4d: Metformin 1000 mg bid (Except for 500 mg after 1d lunch)

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Jae-Yong Chung · Seoul National University Bundang Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03809260 on ClinicalTrials.gov