A Study to Compare the Blood Levels of Sildenafil Following Administration of an Experimental Tablet vs. the Conventional Oral Tablet in Healthy Subjects

An Open-Label, Crossover Study In Healthy Volunteers To Evaluate The Pharmacokinetics Of Sildenafil Following Administration Of An Experimental Tablet Of Sildenafil With Or Without Water Relative To Viagra® Conventional Oral Tablet With Water.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00866463

Enrollment

Registered

2009-03-20

Start date

2008-10-31

Completion date

2008-10-31

Last updated

2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Keywords

Sildenafil, Pharmacokinetics, Healthy Volunteer

Brief summary

This study to will compare the blood levels of sildenafil following administration of an experimental tablet vs. the conventional oral tablet.

Interventions

DRUGSildenafil

Single Dose of 50 mg Sildenafil Oral Tablet With Water

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy males between the ages of 18 and 55 years. * Body Mass Index of 18 to 30 kg/m2, and a total body weight \>50 kg (110 lbs).

Exclusion criteria

* Smoking in excess of the equivalent of 5 cigarettes per day. * Treatment with an experimental drug within 30 days or sildenafil, vardenafil, tadalfil within 4 days before first study dose. * Develop blood pressure lowering or experience dizziness, lightheadedness when going from the laying down position to standing position.

Design outcomes

Primary

Measure	Time frame
Blood levels of sildenafil	1 Day

Secondary

Measure	Time frame
Blood levels of a metabolite of sildenafil	1 Day
Side Effects	1 Day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026