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Clinical Study to Investigate the Safety and Pharmacokinetics of SK3530 Tablet in Renal Impaired Male Patients (SK3530_RI_I)

This study has been completed.
Sponsor:
Collaborator:
SK Chemicals Co.,Ltd.
Information provided by (Responsible Party):
Kyun-Seop Bae, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01232010
First received: November 1, 2010
Last updated: January 13, 2015
Last verified: January 2015

November 1, 2010
January 13, 2015
November 2009
December 2011   (final data collection date for primary outcome measure)
Pharmacokinetics (AUC and Cmax) [ Time Frame: 2days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01232010 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Clinical Study to Investigate the Safety and Pharmacokinetics of SK3530 Tablet in Renal Impaired Male Patients
Clinical Study to Investigate the Safety and Pharmacokinetics of Udenafil Tablet in Renal Impaired Male Patients
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Renal Insufficiency
  • Kidney Diseases
  • Urologic Diseases
Drug: Mirodenafil
50mg Single Oral Dose of
  • Experimental: Healthy Volunteers
    Intervention: Drug: Mirodenafil
  • Experimental: Patients with severe renal impairment
    Intervention: Drug: Mirodenafil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
Not Provided
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Male
19 Years to 64 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01232010
2007-0445
No
Not Provided
Not Provided
Kyun-Seop Bae, Asan Medical Center
Asan Medical Center
SK Chemicals Co.,Ltd.
Principal Investigator: Kyun-Seop Bae, M.D., Ph.D. Asan Medical Center
Asan Medical Center
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP