BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 1000mg in Comparison to Each Component Administered Alone

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: gemigliptin and metformin HCl extended release; Drug: gemigliptin/metformin HCl extended release

• Registration Number: NCT01662674
• Lead Sponsor: LG Life Sciences

Brief Summary

This study is to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics of the combinations of gemigliptin 50mg and metformin HCl extended release 1000mg in comparison to each component administered in healthy male volunteers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-06
• Study First Submitted QC: 2012-08-08
• Study First Posted: 2012-08-10
• Study Start: 2012-10
• Primary Completion: 2012-11
• Study Completion: 2013-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-02
• Last Update Posted: 2015-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 27

Inclusion Criteria

• Age between 20 to 45, healthy male subjects(at screening)
• Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
• FPG 70-125mg/dL glucose level(at screening)
• Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria

• Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)
• Subject who had GI tract disease or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
• Subject who had drug hypersensitivity reaction.(Aspirin, antibiotics)
• Subject who already participated in other trials in 3months
• Subject who had whole blood donation in 2months, or component blood donation in 1months or transfusion in 1months currently.
• Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
G+M	gemigliptin and metformin HCl extended release	Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg
C	gemigliptin/metformin HCl extended release	Combination of gemigliptin50mg/metformin HCl extended release 1000mg

Primary Outcome Measures

Name	Time	Method
AUClast	up to 48h post-dose	To evaluate AUClast of gemigliptin and metformin
Cmax	up to 48h post-dose	To evaluate Cmax of gemigliptin and metformin

Secondary Outcome Measures

Name	Time	Method
AUEC	up to 48h post-dose	This parameter is been used to measure pharmarcodynamic characters of gemigliptin and metformin, the supression rate of DPP4 activity.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of