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.
Overview
- Phase
- Phase 1
- Intervention
- "Metformin" and "Rosuvastatin" seperately
- Conditions
- Diabetes
- Sponsor
- Jeil Pharmaceutical Co., Ltd.
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Cmax of Metformin and rosuvastatin
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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/m
- •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.
Arms & Interventions
Group I
Period I: administration of "Metformin" and "Rosuvastatin" seperately Period II: JLP-1310
Intervention: "Metformin" and "Rosuvastatin" seperately
Group I
Period I: administration of "Metformin" and "Rosuvastatin" seperately Period II: JLP-1310
Intervention: JLP-1310
Group II
Period I: JLP-1301 Period II: administration of "Metformin' and "Rosuvastatin" seperately
Intervention: "Metformin" and "Rosuvastatin" seperately
Group II
Period I: JLP-1301 Period II: administration of "Metformin' and "Rosuvastatin" seperately
Intervention: JLP-1310
Outcomes
Primary Outcomes
Cmax of Metformin and rosuvastatin
Time Frame: 48 hours
AUCt of Metformin and rosuvastatin
Time Frame: 48 hours