Evaluating a Pharmacokinetic Drug Interaction between Metformin Hydrochloride and Rosuvastatin Calcium in Healthy Male Subjects
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0000889
- Lead Sponsor
- Hanmi Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 36
1.Healthy male volunteers, age 20 to 55 years.
2.The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
3.Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing
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.Glomerular filtration rate is under 60ml/min which is calculated by serum creatinine value.
3.Liver enzyme (AST, ALT) level exceeds one and a half times more than maximum normal range.
4.Systolic blood pressure <90mmHg or Diastolic blood pressure < 60 mmHg, systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg(Sitting blood pressure) during the screening procedure.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax,ss of metformin, rosuvastatin; AUCt of metformin, rosuvastatin
- Secondary Outcome Measures
Name Time Method tmax,ss of metformin, rosuvastatin; t1/2 of metformin, rosuvastatin;C min,ss of metformin, rosuvastatin