Investigate the Effect of Food on the Pharmacokinetics of JLP-1310 in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
A randomized, open-label, single dose, crossover study to investigate the effect of food on the pharmacokinetics of JLP-1310 in healthy male volunteers.

Detailed Description
-----------------
A randomized, open-label, single dose, crossover clinical trial.

Official Title
-----------------
A Randomized, Open-label, Single Dose, Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of JLP-1310 in Healthy Male Volunteers

Conditions
-----------------
Diabetes, Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: JLP-1310, Fasted followed by fed
* Drug: JLP-1310, Fed followed by fasted


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteer, age is over 19 years Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 17.5 kg/m2 , no more than 30.5 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. Hypertension(Systolic BP ≥ 140mmHG or Diastolic BP ≥ 90mmHg), Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times. 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
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JLP-1310, Fasted followed by fed<br>JLP-1310 dosing in the fasted state followed by fed dosing Interventions: Drug: JLP-1310 | Drug: JLP-1310, Fasted followed by fed<br>* In period 1, the subjects will receive an oral pill of JLP-1310 under fasted condition. In period 2, the subjects will receive an oral pill of JLP-1310 under fed condition.<br>* Other names: metformin hydrochloride, rosuvastatin calcium;|
| Experimental: JLP-1310, Fed followed by fasted<br>JLP-1310 dosing in the fasted state followed by fed dosing Interventions: Drug: JLP-1310 | Drug: JLP-1310, Fed followed by fasted<br>* In period 1, the subjects will receive an oral pill of JLP-1310 under fed condition. In period 2, the subjects will receive an oral pill of JLP-1310 under fasted condition.<br>* Other names: metformin hydrochloride, rosuvastatin calcium;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax |  | 48 hours from baseline | 
| AUC(last) |  | 48 hours from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC(inf) |  | 48 hours from baseline | 
| Tmax |  | 48 hours from baseline | 
| T1/2 |  | 48 hours from baseline | 
| CL/F |  | 48 hours from baseline | 
| Vd/F |  | 48 hours from baseline |