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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Gemigliptin
* Drug: Irbesartan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemigliptin<br>Gemigliptin 50mg q.d. during 7 days | Drug: Gemigliptin<br> <br> |
| Experimental: Irbesartan<br>Irbesartan 300mg q.d. during 7 days | Drug: Irbesartan<br> <br> |
| Experimental: Gemiglitin + Irbesartan<br>Gemigliptin 50mg + Irbesartan 300mg q.d. during 7 days | Drug: Gemigliptin<br> <br> Drug: Irbesartan<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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