The hypothesis for the trial is that the Sildenafil Citrate Powder for Oral Suspension (10 Mg/ml) bioequivalent to the Revatio 20 Mg IR tablet in Healthy Volunteers and the Sildenafil Citrate 10 Mg immediate release (IR) tablet is bioequivalent to the Revatio 20 Mg IR tablet in Healthy Volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Single oral dose of 1 x 20 mg IR oral tablet.
single oral dose of 2 x 10 mg sildenafil citrate IR oral tablet.
single oral dose of 2 mL of the 10 mg/mL sildenafil citrate POS (20 mg dose).
Pfizer Investigational Site
Brussels, Belgium
Area under the curve (AUC0-T) of sildenafil plasma concentrations from time zero to the time T of last measurable concentration.
Time frame: Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose
Maximum sildenafil plasma concentration (Cmax)
Time frame: Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose
AUCinf, AUC of sildenafil from time zero to time infinity. AUCinf = AUC0-T+AUCextrapolated
Time frame: Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose
AUC%extrapolated of sildenafil.
Time frame: Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose
Tmax - time at which maximum sildenafil plasma concentration occurs
Time frame: Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose
Adverse events
Time frame: From FSFV to LSLV, up to 5 weeks
terminal half-life of sildenafil.
Time frame: Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose
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