Clinical Trial to Investigate the Pharmacokinetics Drug Interaction Between Metformin and Rosuvastatin

Study Overview
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Brief Summary
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The purpose of this study is to investigate the pharmacokinetic drug interaction between Metformin and Rosuvastatin in healthy male volunteers.

Detailed Description
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Drug-drug Interaction Following Co-administration of Metformin and Rosuvastatin in Healthy Male Volunteers

Official Title
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An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Drug-drug Interaction Following Coadministration of Metformin and Rosuvastatin in Healthy Male Volunteers

Conditions
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Hyperlipidemia, Diabetes

Intervention / Treatment
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* Drug: Metformin
* Drug: Rosuvastatin
* Drug: Metformin and Rosuvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19 55 years healthy male BMI measurement 19.0kg/m^2  28.0kg/m^2 Signed informed consent form from to participate voluntarily and to comply with the trial requirements. Exclusion Criteria: History of clinically significant kidney, liver, gastro-intestinal system, cardiovascular system, respiratory system, tumor or blood disorders, nervous system, immune system, endocrine disorders, cardiovascular diseases, mental disorders (mood disorders, obsessive-compulsive disorder, etc.) SBP>140mmHg or <90mmHg, DBP>90mmHg or <60mmHg. An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason. History of drug abuse A alcohol consumer(alcohol>140g/week) or smoker(cigarette>10 cigarettes/day) Hypersensitivity reaction in history of investigational drugs or specific drugs(aspirin, antibiotics) Administrated investigational product in a previous clinical trial within 60 days of the screening day in this study. Administrated drugs which can inhibit or induce OCT2, OATP1B1 transporter within 30 days of the screening day in this study.(ex: proton pump inhibitor, rifampicin) Glomerular filtration rate<60mL/min Donated blood within 60 days prior to the screening day or apheresis blood within 30 days prior to the screening day .

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 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: Metformin<br>Metformin and Rosuvastatin: Volunteers will be taken Metformin-Rosuvastatin-Co-administration | Drug: Metformin<br>* Metformin,1000mg, once daily<br>* Other names: Glucodown OR SR tablet;Drug: Rosuvastatin<br>* Rosuvastatin, 20 mg, once daily<br>* Other names: Crestor tablet;Drug: Metformin and Rosuvastatin<br>* Metformin, 1000mg, once daily Rosuvastatin, 20mg, once daily<br>* Other names: Glucodown OR SR tablet and Crestor tablet;|
| Experimental: Rosuvastatin<br>Metformin and Rosuvastatin: Volunteers will be taken Rosuvastatin-Co-administration-Metformin | Drug: Metformin<br>* Metformin,1000mg, once daily<br>* Other names: Glucodown OR SR tablet;Drug: Rosuvastatin<br>* Rosuvastatin, 20 mg, once daily<br>* Other names: Crestor tablet;Drug: Metformin and Rosuvastatin<br>* Metformin, 1000mg, once daily Rosuvastatin, 20mg, once daily<br>* Other names: Glucodown OR SR tablet and Crestor tablet;|
| Experimental: Co-administration<br>Metformin and Rosuvastatin: Volunteers will be taken Co-administration-Metformin-Rosuvastatin | Drug: Metformin<br>* Metformin,1000mg, once daily<br>* Other names: Glucodown OR SR tablet;Drug: Rosuvastatin<br>* Rosuvastatin, 20 mg, once daily<br>* Other names: Crestor tablet;Drug: Metformin and Rosuvastatin<br>* Metformin, 1000mg, once daily Rosuvastatin, 20mg, once daily<br>* Other names: Glucodown OR SR tablet and Crestor tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax,ss, AUCτ |  | 32h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax,ss |  | 32h | 
| t1/2 |  | 32h | 
| Cmin,ss |  | 32h | 
| CL/Fss |  | 32h | 
| Vd/Fss |  | 32h |