NCT02712619

Brief Summary

Two doses of metformin with 12 hour interval

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
Last Updated

March 18, 2016

Status Verified

March 1, 2016

Enrollment Period

4 months

First QC Date

February 22, 2016

Last Update Submit

March 14, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • Maximum plasma concentration

    0-12 hour

  • Area under the metformin concentration curve

    0-12 hour

  • Area under the glucose curve

    2-5 hour

Study Arms (2)

metformin 250mg

EXPERIMENTAL

metformin 375/250 mg

Drug: Metformin

metformin 1000mg

EXPERIMENTAL

metformin 1000/1000 mg

Drug: Metformin

Interventions

MetforminDRUG
metformin 1000mgmetformin 250mg

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29342199DERIVED

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 22, 2016

First Posted

March 18, 2016

Study Start

May 1, 2014

Primary Completion

September 1, 2014

Last Updated

March 18, 2016

Record last verified: 2016-03