NCT01443221

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: JW Pharmaceutical · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	mitiglinide and metformin	Free combination of Mitiglinide 10mg and Metformin 500mg
DRUG	mitiglinide and metformin	Fixed-dose combination of Mitiglinide 10mg and Metformin 500mg

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2011-09-29
• Last updated: 2011-09-29

Locations

1 site across 1 country: South Korea