Pharmacokinetic-Pharmacodynamic Relationship of Metformin in Healthy Volunteers

NCT ID: NCT02712619

Last Updated: 2016-03-18

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

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Brief Summary

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Two doses of metformin with 12 hour interval

* low dose group (375/250 mg)
* high dose group (1000/1000mg)

Detailed Description

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A study to evaluate and compare the pharmacokinetic-pharmacodynamic relationship between different metformin dose groups.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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metformin 250mg

metformin 375/250 mg

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

metformin 1000mg

metformin 1000/1000 mg

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Interventions

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Metformin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 20 to 45
* Body weight 50 to 100 kg
* fasting serum glucose 70 to 125 mg/dL
* who provide informed consent voluntarily

Exclusion Criteria

* any significant renal, gastrointestinal, hepatic, and metabolic condition
* any co/prior medication within 14 days of study drug administration
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jae Yong Chung

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Chung H, Oh J, Yoon SH, Yu KS, Cho JY, Chung JY. A non-linear pharmacokinetic-pharmacodynamic relationship of metformin in healthy volunteers: An open-label, parallel group, randomized clinical study. PLoS One. 2018 Jan 17;13(1):e0191258. doi: 10.1371/journal.pone.0191258. eCollection 2018.

Reference Type DERIVED
PMID: 29342199 (View on PubMed)

Other Identifiers

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MP0

Identifier Type: -

Identifier Source: org_study_id

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