A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial to Compare 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

LG Life Sciences1 site in 1 country27 target enrollmentOctober 2012

ConditionsHealthy

Interventionsgemigliptin and metformin HCl extended release gemigliptin/metformin HCl extended release

Drugsgemigliptin and metformin HCl extended release gemigliptin/metformin HCl extended release

Overview

Phase: Phase 1
Intervention: gemigliptin and metformin HCl extended release
Conditions: Healthy
Sponsor: LG Life Sciences
Enrollment: 27
Locations: 1
Primary Endpoint: AUClast
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

March 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

LG Life Sciences

Responsible Party

Sponsor

Eligibility Criteria

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)