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A 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 (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00866463
First received: March 19, 2009
Last updated: February 12, 2013
Last verified: February 2013
History of Changes

March 19, 2009
February 12, 2013
October 2008
October 2008   (final data collection date for primary outcome measure)
Blood levels of sildenafil [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00866463 on ClinicalTrials.gov Archive Site
  • Blood levels of a metabolite of sildenafil [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Side Effects [ Time Frame: 1 Day ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

This study to will compare the blood levels of sildenafil following administration of an experimental tablet vs. the conventional oral tablet.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Erectile Dysfunction
  • Drug: Sildenafil
    Single Dose of 50 mg Sildenafil Oral Tablet With Water
  • Drug: Sildenafil
    Single Dose of 50 mg Sildenafil Experimental Tablet With Water
  • Drug: Sildenafil
    Single Dose of 50 mg Sildenafil Experimental Tablet Without Water
  • Active Comparator: Conventional Oral Tablet With Water
    Intervention: Drug: Sildenafil
  • Experimental: Experimental Tablet With Water
    Intervention: Drug: Sildenafil
  • Experimental: Experimental Tablet Without Water
    Intervention: Drug: Sildenafil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
October 2008
October 2008   (final data collection date for primary outcome measure)

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.
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00866463
A1481265
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP