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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01747083

Enrollment

Registered

2012-12-11

Start date

2013-01-31

Completion date

2013-04-30

Last updated

2013-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief summary

This study is designed to investigate the food-effects on FDC(gemigliptin/metformin HCl sustained release) 50/1000mg(25/500mg x 2tablets)

Interventions

DRUGFDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets))

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
AUClast	up to 48 h post-dose	To evaluate AUClast of gemigliptin and metformin
Cmax	up to 48 h post-dose	TO evaluate Cmax of gemigliptin and metformin

Secondary

Measure	Time frame	Description
t1/2	up to 48 h post-dose	To evaluate t1/2 of gemigliptin, metformin and LC15-0636(active metabolite of gemigliptim)
AUCinf	up to 48 h post-dose	To evaluate AUCinf of gemigliptin,metformin and LC15-0636(active metabolite of gemigliptin)
AUClast	up to 48h post-dose	To evaluate AUClast of LC15-0636(active metabolite of gemigliptim)
Cmax	up to 48h post-dose	To evaluate Cmax of LC15-0636(active metabolite of gemigliptim)
Tmax	up to 48h post-dose	To evaluate Tmax of gemigliptin, metformin and LC15-0636(active metabolite of gemigliptim)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026