The bioavailability of the oral disintegrating tablet formulations given without water will be similar to an equivalent dose of the standard oral tablet given with water.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
16
Commercial tablet, 50 mg, single dose administered with water
Oral disintegrating tablet (ODT), 50 mg, single dose administered without water
ODT, 50 mg, single dose administered without water
Pfizer Investigational Site
New Haven, Connecticut, United States
AUC0-T and Cmax of sildenafil
Time frame: 1 month
AUC0-Tmax and AUCinf of sildenafil
Time frame: 1 month
Tmax and half-life of sildenafil
Time frame: 1 month
adverse events
Time frame: 3 weeks
vital signs
Time frame: 3 weeks
laboratory parameters
Time frame: 3 weeks
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ODT, 50 mg, single dose, administered without water