Pharmacokinetic Drug Interaction Study Between Gemigliptin and Glimepiride in Healthy Male Subjects

Study Overview
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Brief Summary
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The objective of the study was to investigate the pharmacokinetic drug interaction between gemigliptin and glimepiride in healthy male subjects after oral administration concomitantly and each alone.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Gemigliptin and Glimepiride
* Drug: Glimepiride


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 (at screening) 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 or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included) Subject who had drug hypersensitivity reaction.(gemigliptin, glimepiride, aspirin, antibiotics) Subject who already participated in other trials in 90 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemigliptin and Glimepiride<br>Multiple administrations of gemigliptin and single concomitant administration of gemigliptin and glimepiride | Drug: Gemigliptin and Glimepiride<br>* Gemigliptin 50mg (qd) on Day1 Day6 and Gemigliptin 50mg (qd) and Glimepiride 4mg (qd) on Day7<br>|
| Experimental: Glimepiride<br>Single administration of glimepiride | Drug: Glimepiride<br>* Glimepiride 4mg (qd) on Day1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC | To evaluate AUCτ,ss of gemigliptin and AUClast of glimepiride | up to 24h post-dose | 
| Cmax | To evaluate Cmax,ss of gemigliptin and Cmax of glimepiride | up to 24h post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax | To evaluate Tmax,ss of gemigliptin/LC15-0636 and Tmax of glimepiride/M1 | up to 24h post-dose | 
| t1/2β | To evaluate t1/2β of gemigliptin/LC15-0636/glimepiride/M1 | up to 24h post-dose | 
| AUC | To evaluate AUCτ,ss of LC15-0636 and AUClast of M1 | up to 24h post-dose | 
| Cmax | To evaluate Cmax,ss of LC15-0636 and Cmax of M1 | up to 24h post-dose |