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.
Information provided by:
Pfizer Identifier:
First received: November 19, 2008
Last updated: May 6, 2010
Last verified: May 2010
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:

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


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00795938

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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. 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
Genital Diseases, Male
Mental Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sildenafil Citrate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Urological Agents
Vasodilator Agents processed this record on May 25, 2016