To Compare the Pharmacokinetics of Avanafil in Subjects With Mild and Moderate Renal Impairment to Subjects With Normal Renal Function.
NCT01054261 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2011-01-07
Summary
The objective of this study is to compare the pharmacokinetics of avanafil in subjects with mild and moderate renal impairment and to assess the safety and toleration of avanafil in subjects with mild and moderate renal impairment.
Conditions
Interventions
- DRUG
-
avanafil
200 mg avanafil tablet QD
Sponsors & Collaborators
-
VIVUS LLC
lead INDUSTRY
Principal Investigators
-
Shiyin Yee · VIVUS LLC
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 78 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-01-31
- Primary Completion
- 2010-02-28
- Completion
- 2010-02-28
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