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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01231997
Recruitment Status : Completed
First Posted : November 2, 2010
Last Update Posted : November 2, 2010
Sponsor:
Collaborator:
Dong-A Pharmaceutical Co., Ltd.
Information provided by:
Asan Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Renal Insufficiency Kidney Diseases Urologic Diseases Drug: Udenafil Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Clinical Study to Investigate the Safety and Pharmacokinetics of Udenafil Tablet in Renal Impaired Male Patients
Study Start Date : November 2009
Actual Primary Completion Date : November 2010

Arm Intervention/treatment
Experimental: Healthy Volunteers Drug: Udenafil
100mg Single Oral Dose of

Experimental: Patients with mild renal impairment Drug: Udenafil
100mg Single Oral Dose of

Experimental: Patients with moderate renal impairment Drug: Udenafil
100mg Single Oral Dose of

Experimental: Patients with severe renal impairment Drug: Udenafil
100mg Single Oral Dose of




Primary Outcome Measures :
  1. Pharmacokinetics (AUC and Cmax) [ Time Frame: up to 48 hours ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: up to 48 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01231997


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
Dong-A Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Kyun-Seop Bae, M.D., Ph.D. Asan Medical Center
Additional Information:
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Responsible Party: Clinical Development Team1, Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01231997    
Other Study ID Numbers: 2006-0431
First Posted: November 2, 2010    Key Record Dates
Last Update Posted: November 2, 2010
Last Verified: October 2010
Keywords provided by Asan Medical Center:
Udenafil
DA-8159
renal impairment
healthy volunteers
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency
Urologic Diseases
Udenafil
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action