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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01231997 |
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Date of registration:
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01/11/2010 |
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Primary sponsor: |
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Public title:
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Clinical Study to Investigate the Safety and Pharmacokinetics of Udenafil Tablet in Renal Impaired Male Patients
DA8159_RI_I |
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Scientific title:
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Clinical Study to Investigate the Safety and Pharmacokinetics of Udenafil Tablet in Renal Impaired Male Patients |
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Date of first enrolment:
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November 2009 |
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Target sample size:
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27 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01231997 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Kyun-Seop Bae, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Asan Medical Center |
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Key inclusion & exclusion criteria
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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.
Age minimum:
19 Years
Age maximum:
64 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Kidney Diseases
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Renal Insufficiency
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Urologic Diseases
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Intervention(s)
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Drug: Udenafil
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Primary Outcome(s)
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Pharmacokinetics (AUC and Cmax)
[Time Frame: up to 48 hours]
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Secondary Outcome(s)
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Safety
[Time Frame: up to 48 hours]
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Secondary ID(s)
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2006-0431
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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