Pharmacokinetic-Pharmacodynamic Relationship of Metformin... | NCT02712619

Studies
Pharmacokinetic-Pharmacodynamic Relationship of Metformin in Healthy Volunteers

NCT02712619

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Mar 18, 2016Estimated

Enrollment

20Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Metformin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Sep 2014Actual

Completion Date

Not provided

First Submitted Date

Feb 22, 2016

First Submission Date that Met QC Criteria

Mar 14, 2016

First Posted Date

Mar 18, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2016

Last Update Posted Date

Mar 18, 2016Estimated

Description Module

Brief Summary

Two doses of metformin with 12 hour interval

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
metformin 250mg	Experimental	metformin 375/250 mg	Drug: Metformin
metformin 1000mg	Experimental	metformin 1000/1000 mg	Drug: Metformin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Metformin	Drug		metformin 1000mg metformin 250mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum plasma concentration		0-12 hour
Area under the metformin concentration curve		0-12 hour
Area under the glucose curve		2-5 hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29342199	Derived	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.

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals