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CompletedNCT02056600Updated May 8, 2014

BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 1000mg in Comparison to Each Component Administered Alone.

A Phase 1 interventional study of gemigliptin and metformin HCl extended release and gemigliptin/metformin HCl sustained release in Healthy, sponsored by LG Life Sciences. Completed at 1 site in Korea, Republic of. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-08.

Sponsored by LG Life Sciences · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Male
01

Study summary

This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of gemigliptin 50mg and metformin HCl extended release 1000mg in comparison to each component administered in healthy male volunteers.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

LG Life Sciences is the lead sponsor of 75 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    G+M

    Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg

    Drug: gemigliptin and metformin HCl extended release

  • Experimental
    C

    Combination of gemigliptin50mg/metformin HCl sustained release 1000mg

    Drug: gemigliptin/metformin HCl sustained release

Interventions

  • Druggemigliptin and metformin HCl extended release

    Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg, for 1 day

  • Druggemigliptin/metformin HCl sustained release

    Administration of combination of gemigliptin 50mg/metformin HCl sustained release 1000mg, for 1day.

06

What researchers measure

Primary outcomes

  1. AUClast

    To evaluate AUClast of gemigliptin and metformin

    Time frame: up to 48h post-dose

  2. Cmax

    To evaluate Cmax of gemigliptin and metformin

    Time frame: up to 48h post-dose

07

Study locations

1 site
  • Asan Medical Center
    Seoul, Korea, Republic of
08

References and documents

Publications

  • Cho YS, Lee SH, Lim HS, Bae KS. Pharmacokinetic Equivalence of the High Dose Strength Fixed-Dose Combination Tablet of Gemigliptin/Metformin Sustained Release (SR) and Individual Component Gemigliptin and Metformin XR Tablets in Healthy Subjects. J Korean Med Sci. 2018 Sep 5;33(41):e258. doi: 10.3346/jkms.2018.33.e258. eCollection 2018 Oct 8. PubMed 30288156 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02056600
Lead sponsor
LG Life Sciences
Responsible party
Sponsor
First posted
Feb 6, 2014
Start date
Mar 2014
Primary completion
Apr 2014
Completion
May 2014
Last update
May 8, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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