NCT03787017

A Study to Compare MP-513 20mg & Metformin XR 1000mg FDC With Coadministration of the Two Separate Drugs

A Randomized, Open-label, Single-dosing, 2X2 Crossover Study to Compare the Safety and Pharmacokinetics of FDC of MP-513 20mg and Metformin XR 1000mg With Coadministration of the Two Separate Drugs in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (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 20mg and Metformin XR 1000mg with coadministration of the two separate drugs in healthy male volunteers.

Detailed description

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

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	FDC(MP-513 20mg/Metformin XR 1000mg)
DRUG	MP-513 20mg
DRUG	Metformin XR 1000mg

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-08-01
• Completion: 2014-09-01
• First posted: 2018-12-26
• Last updated: 2018-12-27

Locations

1 site across 1 country: South Korea