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CompletedNCT01825850Updated Dec 30, 2014

Pharmacokinetic Drug Interaction Study Between Gemigliptin and Irbesartan After Oral Administration in Healthy Male Subjects

A Phase 1 interventional study of Gemigliptin and Irbesartan 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 2014-12-30.

Sponsored by LG Life Sciences · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Male
01

Study summary

The objective of the study is to investigate the drug interaction between Gemigliptin and Irbesartan by comparing pharmacokinetics of Gemigliptin and Irbesartan administered concomitantly and each alone in healthy male subjects.

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

  • Age between 20 to 45, healthy male subjects (at screening)

    • BMI between 18 - 27 kg/m2 (at screening)
    • Blood pressure SBP 90-140 mmHg, DBP 60-95 mmHg
    • 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

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 that influencable to drug absorption or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
    • Subject who had drug hypersensitivity reaction.(gemigliptin, irbesartan, aspirin, antibiotics)
    • Subject who already admitted in other investigator product in 80 days
    • Subject who had whole blood donation in 60 days, or component blood donation in 30 days or transfusion in 30 days currently
05

Study design

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

Study arms

  • Experimental
    Gemigliptin

    Gemigliptin 50mg q.d. during 7 days

    Drug: Gemigliptin

  • Experimental
    Irbesartan

    Irbesartan 300mg q.d. during 7 days

    Drug: Irbesartan

  • Experimental
    Gemiglitin + Irbesartan

    Gemigliptin 50mg + Irbesartan 300mg q.d. during 7 days

    Drug: Gemigliptin · Drug: Irbesartan

Interventions

  • DrugGemigliptin
  • DrugIrbesartan
06

What researchers measure

Primary outcomes

  1. Cmax,ss

    To evaluate Cmax,ss of Gemigliptin and Irbesartan

    Time frame: up to 72h post-dose

  2. AUCτ,ss

    To evaluate AUCτ,ss of Gemigliptin and Irbesartan

    Time frame: up to 72h post-dose

Secondary outcomes

  1. Cmin,ss

    To evaluate Cmin,ss of Gemigliptin and Irbesartan

    Time frame: up to 72h post-dose

  2. Tmax,ss

    To evaluate Tmax,ss of Gemigliptin, Irbesartan and LC15-0636 (active metaboilite of Gemigliptin)

    Time frame: up to 72h post-dose

  3. Cmax,ss

    To evaluate Cmax,ss of LC15-0636 (active metaboilite of Gemigliptin)

    Time frame: up to 72h post-dose

  4. AUCτ,ss

    To evaluate AUCτ,ss of LC15-0636(active metabolite of Gemigliptin)

    Time frame: up to 72h post-dose

  5. metabolic ratio

    To evaluate metabolic ratio of LC15-0636(active metabolite of Gemigliptin)

    Time frame: up to 72h post-dose

07

Study locations

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

References and documents

Publications

  • Choi HY, Lim HS, Kim YH, Jeon HS, Kim MJ, Lee SH, Jung JH, Lee YK, Kim HJ, Bae KS. Evaluation of the pharmacokinetics of the DPP-4 inhibitor gemigliptin when coadministered with rosuvastatin or irbesartan to healthy subjects. Curr Med Res Opin. 2015 Feb;31(2):229-41. doi: 10.1185/03007995.2014.980886. Epub 2014 Nov 6. PubMed 25350224 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01825850
Lead sponsor
LG Life Sciences
Responsible party
Sponsor
First posted
Apr 8, 2013
Start date
Jun 2013
Primary completion
Sep 2013
Completion
Mar 2014
Last update
Dec 30, 2014

Oversight

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

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

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