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

NCT01232010 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-01-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Mirodenafil

50mg Single Oral Dose of

Sponsors & Collaborators

  • SK Chemicals Co., Ltd.

    collaborator INDUSTRY

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Kyun-Seop Bae, M.D., Ph.D. · Asan Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
64 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01232010 on ClinicalTrials.gov