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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00795938

Purpose

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

Condition	Intervention	Phase
Erectile Dysfunction	Drug: Sildenafil	Phase I

MedlinePlus related topics: Drinking Water Erectile Dysfunction

Drug Information available for: Sildenafil citrate Sildenafil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Official Title:	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.

Further study details as provided by Pfizer:

Primary Outcome Measures:

Blood levels of sildenafil [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Blood levels of a metabolite of sildenafil [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Safety [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	18
Study Start Date:	October 2008
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Conventional Oral Tablet With Water: Active Comparator	Drug: Sildenafil Single Dose of 50 mg Sildenafil Oral Tablet With Water
Experimental Tablet With Water: Experimental	Drug: Sildenafil Single Dose of 50 mg Sildenafil Experimental Tablet With Water
Experimental Tablet Without Water: Experimental	Drug: Sildenafil Single Dose of 50 mg Sildenafil Experimental Tablet Without Water

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00795938

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

United States, Connecticut
Pfizer Investigational Site	Recruiting
New Haven, Connecticut, United States, 06511

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A1481266
Study First Received:	November 19, 2008
Last Updated:	November 19, 2008
ClinicalTrials.gov Identifier:	NCT00795938
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Mental Disorders
Sildenafil

Healthy
Genital Diseases, Male
Erectile Dysfunction

Additional relevant MeSH terms:

Vasodilator Agents
Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Enzyme Inhibitors
Cardiovascular Agents
Sexual and Gender Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009