KCT0000489
Recruiting
未知
Clinical trial to assess the pharmacokinetic characteristics of Lodivixx tab. 5/160mg in healthy male subjects
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
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Years 20\-45
- •2\) Body weight\=50kg and 18\=BMI\=29kg/m2
- •3\) volunteer
Exclusion Criteria
- •1\) Subject with serious active cardiovascular, respiratory, hepatologic, 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 laboratory test i. AST(sGOT) or ALT(sGPT) \> Upper normal limit × 1\.5 ii. Total bilirubin \> Upper normal limit × 1\.5 iii. reanl failure with Creatinine clearance \< 50mL/min
- •6\) Clinically significant hypotension when screening period (SBP\<100mmHg, DBP\<60mmHg)
- •7\) Positive test results for HBs Ab, HCV Ab, Syphilis regain test
- •8\) Use of any prescription medication within 14 days prior to study medication dosing
- •9\) Use of any medication such as over\-the\-counter medication including oriental medication within 7 days prior to study medication dosing
- •10\) Subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug)
Outcomes
Primary Outcomes
Not specified
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