The PK Characteristics of the Co-administration of Metformin SR and Rosuvastatin and JLP-1310 in Healthy Male Volunteers.

Study Overview
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Brief Summary
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A randomized, open-label, single dose, crossover study to compare the pharmacokinetic characteristics of the co-administration of metformin SR and rosuvastatin and JLP-1310 in healthy male volunteers.

Official Title
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A Randomized, Open-label, Single Dose, Crossover Study to Compare the Pharmacokinetic Characteristics of the Co-administration of Metformin SR and Rosuvastatin and JLP-1310 (1000/10mg) in Healthy Male Volunteers.

Conditions
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Diabetes, Hyperlipidemias

Intervention / Treatment
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* Drug: Metformin and Rosuvastatin seperately
* Drug: JLP-1310


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteer, age is over 19 years Body weight is over 50 kg, The result of Body Mass Index(BMI) is not less than 18.0 kg/m2 , no more than 29.0 kg/m2. Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial. Subject who has the ability and willingness to participate the whole period of trial. Exclusion Criteria: Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system. Subjects who are allergic to investigational drug. Subjects who have a medical history which can affect the clinical trial. 100 mmHg ≥ Systolic BP ≥ 150mmHg or 55 mmHg ≥ Diastolic BP ≥ 95 mmHg AST or ALT > X 2 UNL Total bilirubin > 2.0 mg/dL CK > X 2 UNL eGFR < 60 mL/min/1.73m2 History of drug abuse or positive drug screening. Participation in other drug studies within 3 months prior to the drug administration. Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.

Ages Eligible for Study
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Minimum Age: 19 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: Group I<br>Period I: administration of Metformin and Rosuvastatin seperately Period II: JLP-1310 | Drug: Metformin and Rosuvastatin seperately<br>* administration of Metformin and Rosuvastatin seperately<br>Drug: JLP-1310<br>* administration of JLP-1310<br>|
| Experimental: Group II<br>Period I: JLP-1301 Period II: administration of Metformin' and Rosuvastatin seperately | Drug: Metformin and Rosuvastatin seperately<br>* administration of Metformin and Rosuvastatin seperately<br>Drug: JLP-1310<br>* administration of JLP-1310<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt of Metformin and rosuvastatin |  | 48 hours | 
| Cmax of Metformin and rosuvastatin |  | 48 hours |