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Status unknownNCT02670018Updated Feb 2, 2016

BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 2000mg in Comparison to Each Component Administered Alone

A Phase 1 interventional study of gemigliptin and metformin HCl extended release and gemigliptin/metformin HCl extended release in Healthy, sponsored by LG Life Sciences. Status unknown at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-02.

Sponsored by LG Life Sciences · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2016), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
19 Years to 45 Years
Sex
Male
01

Study summary

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 50/2000 mg(25/1000 mg x 2 tablets) in Comparison to Each Component Gemigliptin 50 mg and Metformin HCl Extended Release 2000 mg (1000 mg x 2 tablets) 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
19 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age between 19 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

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 3months
  • 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)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Active comparator
    G+M

    Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg \* 2 tablets

    Drug: gemigliptin and metformin HCl extended release

  • Experimental
    C

    Combination of gemigliptin 25mg/metformin HCl extended release 1000mg \* 2 tablets

    Drug: gemigliptin/metformin HCl extended release

Interventions

  • Druggemigliptin and metformin HCl extended release

    Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg \* 2 tablets, for 1 day

  • Druggemigliptin/metformin HCl extended release

    Administration of combination of gemigliptin 25mg/metformin HCl extended release 1000mg \* 2 tablets, 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

Secondary outcomes

  1. Tmax of Gemigliptin, Metformin

    Time frame: up to 48h post-dose

  2. AUCinf of Gemigliptin, Metformin

    Time frame: up to 48h post-dose

  3. t1/2 of Gemigliptin, Metformin

    Time frame: up to 48h post-dose

  4. CL/F of Gemigliptin, Metformin

    Time frame: up to 48h post-dose

  5. Vd/F of Gemigliptin, Metformin

    Time frame: up to 48h post-dose

  6. AUC0-48h of Gemigliptin metabolite(LC15-0636)

    Time frame: up to 48h post-dose

  7. Cmax of Gemigliptin metabolite(LC15-0636)

    Time frame: up to 48h post-dose

  8. Tmax of Gemigliptin metabolite(LC15-0636)

    Time frame: up to 48h post-dose

  9. AUCinf of Gemigliptin metabolite(LC15-0636)

    Time frame: up to 48h post-dose

  10. t1/2 of Gemigliptin metabolite(LC15-0636)

    Time frame: up to 48h post-dose

  11. CL/F of Gemigliptin metabolite(LC15-0636)

    Time frame: up to 48h post-dose

  12. Vd/F of Gemigliptin metabolite(LC15-0636)

    Time frame: up to 48h post-dose

  13. metabolic ratio(MR) of Gemigliptin metabolite(LC15-0636)

    Time frame: up to 48h post-dose

07

Study locations

1 site
  • Yonsei University College of Medicine
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02670018
Lead sponsor
LG Life Sciences
Responsible party
Sponsor
First posted
Feb 1, 2016
Start date
Aug 2015
Primary completion
Dec 2015
Completion
Mar 2016 (estimated)
Last update
Feb 2, 2016

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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