Status:
COMPLETED
Clinical Study to Investigate the Safety and Pharmacokinetics of SK3530 Tablet in Renal Impaired Male Patients
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
SK Chemicals Co., Ltd.
Conditions:
Renal Insufficiency
Kidney Diseases
Eligibility:
MALE
19-64 years
Phase:
PHASE1
Brief Summary
This study is designed to investigate the effect of renal impairment on the safety and pharmacokinetics of SK3530 in subjects with renal impairment compared to healthy subjects.
Eligibility Criteria
Inclusion
- Adult males aged 19 to 64 years at screening.
- Subjects with body weight ≥ 50 kg and within ±30% of the ideal body weight : Ideal body weight = (height \[cm\] - 100)x0.9.
- Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.
Exclusion
- Subjects with the test results of QTc \> 430 ms or non-sinus cardiac rhythm by ECG analysis.
- Subjects with hypotension or hypertension.
- Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01232010
Start Date
November 1 2009
Last Update
January 15 2015
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea