BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 500mg in Comparison to Each Component Administered Alone
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ClinicalTrials.gov Identifier: NCT01595880 |
Recruitment Status :
Completed
First Posted : May 10, 2012
Last Update Posted : February 3, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: gemigliptin and metformin HCl extended release Drug: gemigliptin/metformin HCl extended release | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 29 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (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 |
Study Start Date : | December 2014 |
Actual Primary Completion Date : | January 2015 |
Actual Study Completion Date : | January 2015 |

Arm | Intervention/treatment |
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Experimental: G+M
Coadministration of gemigliptin 50mg and metformin HCl extended release 500mg
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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
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Drug: gemigliptin/metformin HCl extended release
Administration of combination of gemigliptin 50mg/metformin HCl extended release 500mg, for 1day. |
- AUClast, Cmax [ Time Frame: up to 48h post-dose ]To evaluate AUClast and Cmax of gemigliptin and metformin
- AUCinf, Tmax, t1/2, CL/F, metabolic ratio [ Time Frame: 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

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Ages Eligible for Study: | 20 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595880
Korea, Republic of | |
Seoul National University Hospital | |
Seoul, Korea, Republic of, 110-744 |
Principal Investigator: | Kyung-sang Yu, M.D,Ph.D | Seoul national univ. hospital |
Responsible Party: | LG Life Sciences |
ClinicalTrials.gov Identifier: | NCT01595880 |
Other Study ID Numbers: |
LG-DMCL001 |
First Posted: | May 10, 2012 Key Record Dates |
Last Update Posted: | February 3, 2015 |
Last Verified: | February 2015 |
Metformin Hypoglycemic Agents Physiological Effects of Drugs |