None listed
Conditions
Interventions
Drug : arm A : metformin+rosuvastatin / JLP-1310
arm B : JLP-1310/metformin +rosuvastatin
Sponsors
Jeil Pharmaceutical
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Healthy male volunteer, age is over 19 years Body weight is over 50kg, The result of Body Mass Index(BMI) is not less than 18.0 kg/m2 , no more than 29.0 kg/m2 2) Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial 3) Subject who has the ability and willingness to participate the whole period of trial
Exclusion criteria
Exclusion criteria: 1)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. 2)Subjects who are allergic to investigational drug. 3)Subjects who have a medical history which can affect the clinical trial. 4)Systolic BP = 150mmHg, BP =100mmHg or Diastolic BP= 95mmHg, BP = 55 mmHg 5)AST or ALT > X 2 UNL 6)History of drug abuse or positive drug screening. 7)Participation in other drug studies within 90 days prior to the drug administration. 8)Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCt and Cmax of metformin & rosuvasatin | — |
Secondary
| Measure | Time frame |
|---|---|
| tmax, t1/2, AUC8, CL/F and Vd/F of metformin & rosuvasatin | — |
Countries
Korea, Republic of
Contacts
Public ContactSangheon Cho
Inha University Hospital
Outcome results
None listed