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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Healthy
Intervention	Drug: gemigliptin and metformin HCl extended release Drug: gemigliptin/metformin HCl extended release
Phase	Phase 1
Sponsor	LG Life Sciences
Responsible Party	LG Life Sciences
ClinicalTrials.gov Identifier	NCT01662674
First Received	August 6, 2012
Last Updated	March 28, 2013
Last verified	March 2013

Tracking Information[ + expand ][ + ]

First Received Date	August 6, 2012
Last Updated Date	March 28, 2013
Start Date	October 2012
Estimated Primary Completion Date	March 2013
Current Primary Outcome Measures	AUClast [Time Frame: up to 48h post-dose] [Designated as safety issue: No]To evaluate AUClast of gemigliptin and metformin Cmax [Time Frame: up to 48h post-dose] [Designated as safety issue: No]To evaluate Cmax of gemigliptin and metformin
Current Secondary Outcome Measures	AUEC [Time Frame: up to 48h post-dose] [Designated as safety issue: No]This parameter is been used to measure pharmarcodynamic characters of gemigliptin and metformin, the supression rate of DPP4 activity.

Descriptive Information[ + expand ][ + ]

Brief Title	BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 1000mg in Comparison to Each Component Administered Alone
Official Title	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
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 Provided
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Healthy
Intervention	Drug: gemigliptin and metformin HCl extended release Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg, for 1 day Drug: gemigliptin/metformin HCl extended release Administration of combination of gemigliptin 50mg/metformin HCl extended release 500mg, for 1day.
Study Arm (s)	Experimental: G+M Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg Experimental: C Combination of gemigliptin50mg/metformin HCl extended release 1000mg

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	27
Estimated Completion Date	March 2013
Estimated Primary Completion Date	November 2012
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)
Gender	Male
Ages	20 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	Korea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number	NCT01662674
Other Study ID Numbers	LG-DMCL002
Has Data Monitoring Committee	No
Information Provided By	LG Life Sciences
Study Sponsor	LG Life Sciences
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	March 2013

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