Phase 1
N=12
Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Given With Or Without Food.
Erectile Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT01254396 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2012
Primary outcome: Primary: Maximum Observed Plasma Concentration (Cmax) — 292.60; 121.00 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Sildenafil (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Male
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
292.60; 121.00 | — |
| PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |
813.20; 712.80 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
0.625; 4.000 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] |
838.60; 804.00 | — |
| SECONDARY Plasma Decay Half Life (t1/2) |
3.039; 2.503 | — |
Summary
This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties when given with food and without food.
Eligibility Criteria
Inclusion Criteria
- Otherwise healthy male subjects age 45 years or older with or without erectile dysfunction.
- Body Mass Index (BMI) of 17.5 to 32.5 kg/m2.
- Signed Informed Consent.
Exclusion Criteria
- Evidence or history of clinically significant abnormalities
- Have baseline orthostatic hypotension
- Positive drug screen, excessive alcohol and tobacco use
Data sourced from ClinicalTrials.gov (NCT01254396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.