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The purpose of this study is primarily to evaluate whether taking avanafil with alcohol causes the blood pressure to fall.
The trial is a single-centre double-blind, randomized, placebo-controlled, three-period, three-way crossover study, in which each subject will be randomized to receive each of the following three treatments with a washout period of at least 5 days between treatments:
- Treatment A: a single oral dose of one 200 mg avanafil tablet plus an oral dose of alcohol drink mixed with fruit juice (0.5 g of absolute ethanol per kilogram of body weight).
- Treatment B: a single oral dose of one placebo tablet plus an oral dose of alcohol drink mixed with fruit juice (0.5 g of absolute ethanol per kilogram of body weight).
- Treatment C: a single oral dose of one 200 mg avanafil tablet plus an oral dose of placebo drink mixed with fruit juice.
For each treatment period, Dinamap (or DataScope) automatic measurements of supine blood pressure and pulse rate will be taken pre-dose and every 15 minutes for 4 hours post-dose. Alcohol levels using a breathalyzer will be measured at pre-dose and up to 8 hours post dose during all 3 treatments by designated unblinded personnel. Subjects should be supine for at least 5-10 minutes before the blood pressure and heart rate measurement.
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
avanafil, alcohol, avanafil
Active, not recruiting
Published on BioPortfolio: 2014-08-27T03:16:27-0400
This study is to assess whether treatment with a therapeutic (100 mg) or supratherapeutic (800 mg) dose of avanafil has the potential to cause QT/QTc prolongation in healthy volunteers.
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The inability in the male to have a PENILE ERECTION due to psychological or organ dysfunction.
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Surgical insertion of cylindric hydraulic devices for the treatment of organic ERECTILE DYSFUNCTION.
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