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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Human Microbiome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Part 1

Metformin/Vancomycin

Group Type EXPERIMENTAL

Metformin (part 1)

Intervention Type DRUG

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).

Vancomycin

Intervention Type DRUG

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

Part 2

Metformin

Group Type EXPERIMENTAL

Metformin (part 2)

Intervention Type DRUG

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

Interventions

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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).

Intervention Type DRUG

Vancomycin

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

Intervention Type DRUG

Metformin (part 2)

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

Intervention Type DRUG

Other Intervention Names

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Diabex Tab., 500 mg Vancozin cap., 250 mg Diabex Tab., 500 mg

Eligibility Criteria

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Inclusion Criteria

* Age between 19 to 45, healthy male subjects(at screening)
* Body weight between 50.0 kg - 100.0 kg, BMI between 18.0 - 28.0 kg/m2
* Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria

* Subject who has a past or present history of any diseases following below.(liver, kidney, neurology, immunology, pulmonary, endocrine, hematology, oncology, cardiology, mental disorder)
* Subject who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery (appendectomy, hernioplasty are excluded)
* Serum AST(SGOT), ALT(SGPT)\>1.5 times upper limit of normal range
* MDRD eGFR \<80mL/min/1.73m2
* Subject who had drug (Aspirin, antibiotics) hypersensitivity reaction
* Subject who already participated in other trials in 3 months
* Subject who had whole blood donation in 2 months, or component blood donation in 1 month or transfusion in 1 month currently.

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes