Erectile Dysfunction Clinical Trial
Official title:
A PHASE I, A SINGLE-CENTRE, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, THREE-PERIOD, THREE-WAY CROSSOVER STUDY OF THE HEMODYNAMIC INTERACTIONS OF AVANAFIL AND ALCOHOL IN HEALTHY MALE SUBJECTS
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
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