Study for Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Rosuvastatin

Study Overview
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Brief Summary
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Investigate the pharmacokinetic drug interactions between gemigliptin and rosuvastatin in healthy subjects

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: gemigliptin only
* Drug: rosuvastatin only
* Drug: gemigliptin and rosuvastatin


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, rosuvastatin, 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gemigliptin only<br>Multiple administrations of gemigliptin | Drug: gemigliptin only<br>* gemigliptin 50mg qd on day 1 7<br>|
| Experimental: rosuvastatin only<br>Multiple administrations of rosuvastatin | Drug: rosuvastatin only<br>* rosuvastatin 20mg qd on day 1 7<br>|
| Experimental: gemigliptin and rosuvastatin<br>Multiple administrations of gemigliptin and rosuvastatin | Drug: gemigliptin and rosuvastatin<br>* gemigliptin 50mg, rosuvastatin 20mg qd on day 1 7<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | to evaluate Cmax of gemigliptin and rosuvastatin at steady state | up to 72 hour post dose | 
| AUC | to evaluate AUCt of gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin at steady state | up to 72 hour post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax | to evaluate time of Cmax at steady state, gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin | up to 72 hour post dose | 
| Cmin | to evaluate Cmin of gemigliptin and rosuvastatin at steady state | upto 72 hour post dose | 
| t1/2β | to evaluate half-life of gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin | upto 72 hour post dose | 
| Cmax | to evaluate Cmax of metabolite LC15-0636, N-desmethylrosuvastatin at steady state | upto 72 hour post dose | 
| AUC | to evaluate AUC of metabolite LC15-0636, N-desmethylrosuvastatin at steady state | upto 72 hour post dose | 
| metabolic ratio | to evaluate metabolic ratio of gemiglipin and rosuvastatin | upto 72 hour post dose |