Trials / Completed
CompletedNCT01117038
Drug Interaction Study of Avanafil and Enalapril or Amlodipine
A Phase I, Double-Blind, Randomized, Placebo-Controlled, Two-Period, Two-Cohort Crossover Study to Assess the Potential Interaction of Avanafil on the Pharmacokinetic and/or Hemodynamic Effects of Enalapril or Amlodipine in Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- VIVUS LLC · Industry
- Sex
- Male
- Age
- 40 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to determine the change in the blood pressure and pulse rate, pharmacokinetics and the safety when avanafil is taken with either enalapril or amlodipine.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | avanafil and enalapril | enalapril twice a day for 11 days avanafil/placebo once a day for 2 days |
| DRUG | avanafil and amlodipine | amlodipine 5mg once a day for 16 days avanafil/placebo once a day for 3 days |
Timeline
- Start date
- 2010-04-01
- Primary completion
- 2010-05-01
- Completion
- 2010-05-01
- First posted
- 2010-05-05
- Last updated
- 2011-08-10
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01117038. Inclusion in this directory is not an endorsement.