The purpose of this study is to perform a relative bioavailability study between two formulations of sildenafil citrate.
Bio-equivalence between two formulations of sildenafil citrate
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
47
sildenafil citrate 100 mg CT, single dose without water
sildenafil citrate 100 mg CT, single dose with water
sildenafil citrate 100 mg film-coated tablet (Viagra®), single dose
Pfizer Investigational Site
Bragança Paulista, São Paulo, Brazil
Area Under the Curve (AUC 0-t)
Area under the blood concentration-time profile from time zero to last experimentally determined concentration measured in nanograms\*hour/milliliter (ng\*hr/mL).
Time frame: Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose
Maximum Plasma Concentration (Cmax)
Maximum plasma concentration measured in nanograms per milliliter (ng/mL).
Time frame: Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose
Area Under the Curve From 0 to Infinity (AUC 0-inf )
Area under the blood concentration-time profile from time zero extrapolated to infinite time measured in nanograms \*hour/milliliter (ng\*hr/mL).
Time frame: Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose
Time to Maximum Plasma Concentration (Tmax)
Time at which maximum plasma concentration (Cmax) occurred.
Time frame: Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose
Half-life (T 1/2)
Terminal elimination half-life.
Time frame: Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose
Number of Participants With Clinically Significant Findings in Vital Signs
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Clinically significant abnormalities in blood pressure (BP), pulse, and temperature reported as an adverse event. Clinically significant = values outside the normal range and/or values judged as significant by the investigator (normal range: systolic BP 100-140 mmHg; diastolic BP 60- 90 mmHg; temperature 35-37°Celsius). Pulse rate based on investigator discretion.
Time frame: Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.5, 1, 2, 4, 8 and 12 hours post-dose.