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

NCT01595880 — Phase 1, Completed, 29 participants, LG Life Sciences

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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

Registry	NCT01595880
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	29 (Actual)
Sponsor	LG Life Sciences (Industry)
Conditions	Healthy
Interventions	gemigliptin and metformin HCl extended release, gemigliptin/metformin HCl extended release (Drug)
Dates	start 2014-12-01, primary completion 2015-01-01, completion 2015-01-01, first posted 2012-05-10, last updated 2015-02-03
Locations	1 site in South Korea

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
G+M	Experimental	Drug: gemigliptin and metformin HCl extended release	Coadministration of gemigliptin 50mg and metformin HCl extended release 500mg
C	Experimental	Drug: gemigliptin/metformin HCl extended release	Combination of gemigliptin50mg/metformin HCl extended release 500mg

gemigliptin and metformin HCl extended release (Drug): Coadministration of gemigliptin 50mg and metformin HCl extended release 500mg, for 1 day
gemigliptin/metformin HCl extended release (Drug): Administration of combination of gemigliptin 50mg/metformin HCl extended release 500mg, for 1day.

+Outcome measures

Primary outcomes

AUClast, Cmax [up to 48h post-dose]: To evaluate AUClast and Cmax of gemigliptin and metformin

Secondary outcomes

AUCinf, Tmax, t1/2, CL/F, metabolic ratio [up to 48h post-dose]: 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

+Eligibility

Sex: Male, ages: 20 Years to 45 Years, accepts healthy volunteers

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)

+Locations (1)

Facility	City	Country	Status
Seoul National University Hospital	Seoul	South Korea

+Investigators

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