Healthy
Conditions
Brief summary
The main objective of this study is to estimate the effect of food on sildenafil pharmacokinetics after administration of Powder Oral Suspension (POS) formulation of sildenafil citrate.
Interventions
DRUGsildenafil citrate
2 mL of POS formulation of sildenafil citrate 10 mg/mL (equivalent to 20 mg dose), single dose
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and/or female subjects between the ages of 21 and 55 years * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>45 kg (99 lbs).
Exclusion criteria
* Baseline orthostatic hypotension defined as a ≥20 mm Hg reduction in systolic blood pressure (SBP), a ≥10 mm Hg reduction in diastolic blood pressure (DBP) or the development of significant postural symptoms (dizziness, lightheadedness, vertigo) when going from the supine to standing position. * Subjects who are currently prescribed and/or taking nitrates or nitric oxide donors in any form on either a regular or intermittent basis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Observed Plasma Concentration (Cmax) of sildenafil | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of sildenafil | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose |
Secondary
| Measure | Time frame |
|---|---|
| Plasma Decay Half-Life (t1/2) of sildenafil | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose |
| Maximum Observed Plasma Concentration (Cmax) of UK-103,320 | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of UK-103,320 | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose |
| Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of sildenafil | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of UK-103,320 | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose |
| Plasma Decay Half-Life (t1/2) of UK-103,320 | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of UK-103,320 | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax)of sildenafil | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose |
Countries
Singapore
Outcome results
None listed