Pharmacokinetic-Pharmacodynamic Relationship of Metformin in Healthy Volunteers

An Open-label, Parallel Group Clinical Trial to Investigate the Pharmacokinetics/Pharmacodynamics of 250/1000 mg of Metformin IR After Oral Administration in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02712619

Enrollment

Registered

2016-03-18

Start date

2014-05-31

Completion date

Unknown

Last updated

2016-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGMetformin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026