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

A Randomized, Open Label Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Irbesartan in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01825850

Enrollment

Registered

2013-04-08

Start date

2013-06-30

Completion date

2014-03-31

Last updated

2014-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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.

Interventions

DRUGGemigliptin

DRUGIrbesartan

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Cmax,ss	up to 72h post-dose	To evaluate Cmax,ss of Gemigliptin and Irbesartan
AUCτ,ss	up to 72h post-dose	To evaluate AUCτ,ss of Gemigliptin and Irbesartan

Secondary

Measure	Time frame	Description
Cmax,ss	up to 72h post-dose	To evaluate Cmax,ss of LC15-0636 (active metaboilite of Gemigliptin)
Cmin,ss	up to 72h post-dose	To evaluate Cmin,ss of Gemigliptin and Irbesartan
metabolic ratio	up to 72h post-dose	To evaluate metabolic ratio of LC15-0636(active metabolite of Gemigliptin)
AUCτ,ss	up to 72h post-dose	To evaluate AUCτ,ss of LC15-0636(active metabolite of Gemigliptin)
Tmax,ss	up to 72h post-dose	To evaluate Tmax,ss of Gemigliptin, Irbesartan and LC15-0636 (active metaboilite of Gemigliptin)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026