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Clinical Study to Investigate the Safety and Pharmacokinetics of Udenafil Tablet in Renal Impaired Male Patients (DA8159_RI_I)

This study has been completed.
Sponsor:
Collaborator:
Dong-A Pharmaceutical Co., Ltd.
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01231997
First received: November 1, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted

November 1, 2010
November 1, 2010
November 2009
November 2010   (final data collection date for primary outcome measure)
Pharmacokinetics (AUC and Cmax) [ Time Frame: up to 48 hours ]
Same as current
No Changes Posted
Safety [ Time Frame: up to 48 hours ]
Same as current
Not Provided
Not Provided
 
Clinical Study to Investigate the Safety and Pharmacokinetics of Udenafil 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 assess the effect of renal impairment on the pharmacokinetics, safety and tolerability of udenafil in subjects with renal impairment compared to healthy subjects.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Renal Insufficiency
  • Kidney Diseases
  • Urologic Diseases
Drug: Udenafil
100mg Single Oral Dose of
  • Experimental: Healthy Volunteers
    Intervention: Drug: Udenafil
  • Experimental: Patients with mild renal impairment
    Intervention: Drug: Udenafil
  • Experimental: Patients with moderate renal impairment
    Intervention: Drug: Udenafil
  • Experimental: Patients with severe renal impairment
    Intervention: Drug: Udenafil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
Not Provided
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult males aged 19 to 64 years at screening.
  • Subjects with body weight ≥ 55 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 who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study.
  • Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.
Male
19 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01231997
2006-0431
No
Clinical Development Team1, Dong-A Pharmaceutical Co., Ltd.
Asan Medical Center
Dong-A Pharmaceutical Co., Ltd.
Principal Investigator: Kyun-Seop Bae, M.D., Ph.D. Asan Medical Center
Asan Medical Center
October 2010

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