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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00795938
First received: November 19, 2008
Last updated: May 6, 2010
Last verified: May 2010
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
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.

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 18
Study Start Date: October 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional Oral Tablet With Water Drug: Sildenafil
Single Dose of 50 mg Sildenafil Oral Tablet With Water
Experimental: Experimental Tablet With Water Drug: Sildenafil
Single Dose of 50 mg Sildenafil Experimental Tablet With Water
Experimental: Experimental Tablet Without Water 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

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

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

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00795938     History of Changes
Other Study ID Numbers: A1481266
Study First Received: November 19, 2008
Last Updated: May 6, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Sildenafil
Vasodilator Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013