BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 1000mg in Comparison to Each Component Administered Alone.
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02056600 |
Recruitment Status :
Completed
First Posted : February 6, 2014
Last Update Posted : May 8, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: gemigliptin and metformin HCl extended release Drug: gemigliptin/metformin HCl sustained release | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Official Title: | A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of the Combination of Gemigliptin/Metformin HCl Sustained Release 50/1000mg in Comparison to Each Component Gemigliptin 50mg and Metformin HCl Extended Release 1000mg Administered in Healthy Male Volunteers |
Study Start Date : | March 2014 |
Actual Primary Completion Date : | April 2014 |
Actual Study Completion Date : | May 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: G+M
Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg
|
Drug: gemigliptin and metformin HCl extended release
Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg, for 1 day |
Experimental: C
Combination of gemigliptin50mg/metformin HCl sustained release 1000mg
|
Drug: gemigliptin/metformin HCl sustained release
Administration of combination of gemigliptin 50mg/metformin HCl sustained release 1000mg, for 1day. |
- AUClast [ Time Frame: up to 48h post-dose ]To evaluate AUClast of gemigliptin and metformin
- Cmax [ Time Frame: up to 48h post-dose ]To evaluate Cmax of gemigliptin and metformin

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy male adults at age between 20 to 45 at the time of the screening
- ThoseSubjects whose BMI measurement at screening visit is between 18 and 27 kg/m2
- Subjects with fasting plasma glucose (FPG) of 70-125 mg/dL at screening visit
- Subject who has voluntarily decided to participate in this clinical trial and onsented in writing
Exclusion Criteria:
- Subjects who have a past or present clinically significant disease such as hepatic, renal, gastrointestinal, respiratory, musculoskeletal, endocrine, neurological, hemato-oncological, or cardiovascular disorder
- Subjects who have a past history of gastrointestinal disease (e.g. Crohn's disease, ulcer, etc.) or surgery (however, simple appendectomy and hernioplasty are not included) that can affect the absorption of drugs
- Subjects with a medical history of allergic reaction to other drugs including the investigational products or clinically significant hypersensitivity reaction
- Subjects who have a history of drug abuse
- Subjects who have shown positive reaction to drugs that may be abused from a urine drug screening
- Subjects who took other investigational product in other trials within 90 days before the first administration of this investigational product
- Subjects who had whole blood donation within 60 days or component blood donation within 30 days before the first administration of the investigational product, or transfusion within 30 days before the first administration
- Subjects who have taken a drug which is expected to have an effect on the clinical trial within 14 days before the date of the first administration of the investigational product or have had any food that is expected to have an effect on the clinical trial within 7 days (e.g. drinks containing caffeine, grapefruit juice, etc.)
- Subjects who have had alcohol containing drinks 3 times or more per week within one month before the screening visit or cannot abstain from drinking after completing the informed consent form for the participation in the study to the end of the clinical trial
- Subjects who have smoker more than 10 cigarettes per day within the recent one month at the screening visit or cannot refrain from smoking the clinical trial period
- In the vital signs measured in sitting position at the screening visit, subjects who have showed a systolic blood pressure of < 90 mmHg or > 145 mmHg, a diastolic blood pressure of > 95 mmHg or < 60 mmHg) , or a pulse rate of > 110 bpm or < 40 bpm
- Subjects who showed the following findings in the tests conducted during the screening period:
- In excess of 1.5 times the upper normal limit (UNL) in hepatic enzyme (AST and ALT) values
- The creatinine clearance calculated by Cockcroft-Gault equation is 80 mL/min or less
- Positive result in serum test (hepatitis type B test, hepatitis type C test, Human Immunodeficiency Virus (HIV) test, syphilis test)
- QTc > 450 msec in ECG or a clinically significant abnormal rhythm
- Subjects who are considered to be unsuitable in conducting the clinical trial for other reason at the principal investigator's discretionary judgment

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): NCT02056600
Korea, Republic of | |
Asan Medical Center | |
Seoul, Korea, Republic of |
Responsible Party: | LG Life Sciences |
ClinicalTrials.gov Identifier: | NCT02056600 |
Other Study ID Numbers: |
LG-DMCL004 |
First Posted: | February 6, 2014 Key Record Dates |
Last Update Posted: | May 8, 2014 |
Last Verified: | May 2014 |
Metformin Hypoglycemic Agents Physiological Effects of Drugs |