Food-Effect Bioavailability Study of FDC(Gemigliptin/Metformin HCl Sustained Release) 50/1000mg(25/500mg x 2tablets)

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

LG Life Sciences

ClinicalTrials.gov Identifier:

NCT01747083

First received: November 30, 2012

Last updated: February 8, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	November 30, 2012
Last Updated Date	February 8, 2013
Start Date ^ICMJE	January 2013
Estimated Primary Completion Date	March 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 10, 2012)	AUClast [ Time Frame: up to 48 h post-dose ] [ Designated as safety issue: No ] To evaluate AUClast of gemigliptin and metformin Cmax [ Time Frame: up to 48 h post-dose ] [ Designated as safety issue: No ] TO evaluate Cmax of gemigliptin and metformin
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01747083 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 10, 2012)	AUCinf [ Time Frame: up to 48 h post-dose ] [ Designated as safety issue: No ] To evaluate AUCinf of gemigliptin,metformin and LC15-0636(active metabolite of gemigliptin) Tmax [ Time Frame: up to 48h post-dose ] [ Designated as safety issue: No ] To evaluate Tmax of gemigliptin, metformin and LC15-0636(active metabolite of gemigliptim) t1/2 [ Time Frame: up to 48 h post-dose ] [ Designated as safety issue: No ] To evaluate t1/2 of gemigliptin, metformin and LC15-0636(active metabolite of gemigliptim) Cmax [ Time Frame: up to 48h post-dose ] [ Designated as safety issue: No ] To evaluate Cmax of LC15-0636(active metabolite of gemigliptim) AUClast [ Time Frame: up to 48h post-dose ] [ Designated as safety issue: No ] To evaluate AUClast of LC15-0636(active metabolite of gemigliptim)
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Food-Effect Bioavailability Study of FDC(Gemigliptin/Metformin HCl Sustained Release) 50/1000mg(25/500mg x 2tablets)
Official Title ^ICMJE	A Randomized, Open Label, Single Dose, Crossover Study to Investigate Food-effect Bioavailability of FDC(Gemigliptin/Metformin HCl Sustained Release) 50/1000mg(25/500mg x 2tablets)Under Fed and Fasting Conditions in Healthy Male Volunteers
Brief Summary	This study is designed to investigate the food-effects on FDC(gemigliptin/metformin HCl sustained release) 50/1000mg(25/500mg x 2tablets)
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label
Condition ^ICMJE	Type 2 Diabetes
Intervention ^ICMJE	Drug: FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets))
Study Arm (s)	Experimental: A FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mgx2tablets))under fasting condition Intervention: Drug: FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets)) Experimental: B FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mgx2tablets))under fed condition Intervention: Drug: FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets))
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	24
Completion Date	Not Provided
Estimated Primary Completion Date	March 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Age between 20 to 45, healthy male subjects(at screening) BMI between 19.0 - 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 90 days Subject who had whole blood donation in 60 days, or component blood donation in 30 days or transfusion in 30 days currently. Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)
Gender	Male
Ages	20 Years to 45 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01747083
Other Study ID Numbers ^ICMJE	LG-DMCL003
Has Data Monitoring Committee	Not Provided
Responsible Party	LG Life Sciences
Study Sponsor ^ICMJE	LG Life Sciences
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	LG Life Sciences
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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