KCT0001258
Active, not recruiting
未知
A clinical trial to evaluate the pharmacokinetics of the fixed-dose combination of micronized fenofibrate and pitavastatin Ca under fed condition in healthy male volunteers
Hanlim Pharmaceutical0 sites40 target enrollmentTBD
ConditionsDiseases of the circulatory system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the circulatory system
- Sponsor
- Hanlim Pharmaceutical
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Healthy male subjects age 19 to 55 at the screening visit
- •2\) Body weight\=50kg and within Ideal body weight±20%
- •3\) Subject who is judged to be eligible according to clinical laboratory tests including hematological examination, blood chemistry examination, urine analysis and
- •4\) Subject who volunteerly determined to participate in and agreed to comply with precautions after totally understand the detailed explanations about this study
Exclusion Criteria
- •1\) Subject with serious active cardiovascular, respiratory, hepatology, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
- •2\) Subject with symptoms of acute disease within 28days prior to study medication dosing
- •3\) Subject with known for history which affect on the absorption, distribution, metabolism or excretion of drug
- •4\) Subject with clinically significant active chronic disease
- •5\) Subject with any of the following conditions in laboratoy test
- •i. AST(aspartate aminotransferase)or ALT(alanine transferase) \> upper normal limit X 1\.5
- •ii. Total bilirubin \> upper normal limit X 1\.5
- •iii. Renal failure with creatinine clearance \<50mL/min
- •iv. Creatinin phsphokinase \> upper normal limit X 2
- •6\) Positive test results for hepatitis B virus surface antigen, anti\-hepatitis C virus antibody, human immunodeficiency virus antigen/antibody,venereal disease research laboratory test
Outcomes
Primary Outcomes
Not specified
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