BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 500mg in Comparison to Each Component Administered Alone - Full Text View

Purpose

This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of gemigliptin 50mg and metformin HCl extended release 500mg in comparison to each component administered alone in healthy male volunteers.

Condition	Intervention	Phase
Healthy	Drug: gemigliptin and metformin HCl extended release Drug: gemigliptin/metformin HCl extended release	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 500mg in Comparison to Each Component Administered Alone in Healthy Male Volunteers

Resource links provided by NLM:

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by LG Life Sciences:

Primary Outcome Measures:

AUClast, Cmax [ Time Frame: up to 48h post-dose ] [ Designated as safety issue: No ]
To evaluate AUClast and Cmax of gemigliptin and metformin

Secondary Outcome Measures:

AUCinf, Tmax, t1/2, CL/F, metabolic ratio [ Time Frame: up to 48h post-dose ] [ Designated as safety issue: No ]
To evaluate AUCinf, Tmax, t1/2 and CL/F of gemigliptin and metformin, To evaluate AUClast, Cmax and metabolic ratio of gemigliptin metabolite LC15-0636


Enrollment:	29
Study Start Date:	December 2014
Study Completion Date:	January 2015
Primary Completion Date:	January 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: G+M Coadministration of gemigliptin 50mg and metformin HCl extended release 500mg	Drug: gemigliptin and metformin HCl extended release Coadministration of gemigliptin 50mg and metformin HCl extended release 500mg, for 1 day
Experimental: C Combination of gemigliptin50mg/metformin HCl extended release 500mg	Drug: gemigliptin/metformin HCl extended release Administration of combination of gemigliptin 50mg/metformin HCl extended release 500mg, for 1day.

Eligibility


Ages Eligible for Study:	20 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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 2months
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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01595880

Locations


Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744

Sponsors and Collaborators

LG Life Sciences

Investigators


Principal Investigator:	Kyung-sang Yu, M.D,Ph.D	Seoul national univ. hospital

More Information

No publications provided


Responsible Party:	LG Life Sciences
ClinicalTrials.gov Identifier:	NCT01595880 History of Changes
Other Study ID Numbers:	LG-DMCL001
Study First Received:	May 8, 2012
Last Updated:	February 2, 2015
Health Authority:	South Korea: Ministry of Food and Drug Safety

Additional relevant MeSH terms:


Metformin Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 03, 2015