Pharmacokinetics of Mitiglinide and Metformin in Free Combination and Fixed-dose Combination in Healthy Male Subjects.

Open-label, Randomized, Single-dose, 2-way Crossover Study to Investigate Safety and Pharmacokinetics of Mitiglinide and Metformin in Free Combination and Fixed-dose Combination in Healthy Male Subjects.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01443221

Enrollment

Registered

2011-09-29

Start date

2010-12-31

Completion date

2011-01-31

Last updated

2011-09-29

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

Conditions

Healthy

Keywords

mitiglinide, metformin, Pharmacokinetics, Safety

Brief summary

To investigate safety and pharmacokinetics of mitiglinide and metformin in a fixed-dose combination of mitiglinide/metformin, compared with free combination of mitiglinide and metformin in healthy male subjects.

Detailed description

The Korean clinical practice guidelines on DM recommend that a second oral agent with a different mechanism of action be combined to the regimen when adequate glycemic control is difficult to achieve with an oral hypoglycemic agent accompanied dietary therapy. Therefore, a concurrent administration of metformin, a inhibitor of gluconeogenesis, and mitiglinide, an insulin secretagogue, could be an effective and ideal regimen for management of diabetes.

Interventions

DRUGmitiglinide and metformin

Free combination of Mitiglinide 10mg and Metformin 500mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy males * Subject with adequate clinical laboratory test results (hematology, blood chemistry, serology, drug abuse, urinalysis etc.) * Subject with normal results in blood pressure, pulse, body temperature and ECG test * Subject with body mass index (BMI) between 18.5 kg/m2 and to 25 kg/m2

Exclusion criteria

* Clinically significant functional disorder or acute disease * Chronic disease affecting the absorption, metabolism or excretion of drug * Any study drug administration within 90 days before the first drug administration * Use of medicine affecting drug metabolism (inhibition, induction) such as barbital, within 30 days before the first drug administration

Design outcomes

Primary

Measure	Time frame
Compare the pharmacokinetic profiles(Cmax, AUClast) of fixed-dose combination versus free dose combination in healthy volunteers	Up to 36 hours postdose for each period

Secondary

Measure	Time frame
Compare the pharmacokinetic profiles(tmax, t1/2, AUC0-∞) of fixed-dose combination versus free dose combination in healthy volunteers	Up to 36hours postdose for each period

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026