NCT03787043

A Study to Evaluate the Effect of Food on Fixed-Dose Combination of MP-513 10 mg and Metformin XR 750 mg

A Randomized, Open-label, Single-dosing, 2X2 Crossover Study to Evaluate the Effect of Food on the Safety and Pharmacokinetics of Fixed-dose Combination of MP-513 10mg and Metformin XR 750mg in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Handok Inc. · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the safety and pharmacokinetic characteristics of fixed-dose combination of MP-513 10mg and metformin XR 750mg administered in a high fat fed state versus fasting state to healthy male volunteers.

Detailed description

1. Randomized, open-label, single-dosing, two-treatment, two-sequence, two-period, crossover design 2. Wash-out period: 14 days from the first dosing 3. Drug concentration analytical device: UPLC-MS/MS

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	FDC(MP-513 10mg/Metformin XR 750mg)

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2018-12-26
• Last updated: 2018-12-27

Locations

1 site across 1 country: South Korea