Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00866463
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00866463
Recruitment Status : Completed
First Posted : March 20, 2009
Last Update Posted : February 13, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 19, 2009
First Posted Date  ICMJE March 20, 2009
Last Update Posted Date February 13, 2013
Study Start Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2009)
Blood levels of sildenafil [ Time Frame: 1 Day ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00866463 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2009)
  • Blood levels of a metabolite of sildenafil [ Time Frame: 1 Day ]
  • Side Effects [ Time Frame: 1 Day ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Compare the Blood Levels of Sildenafil Following Administration of an Experimental Tablet vs. the Conventional Oral Tablet in Healthy Subjects
Official Title  ICMJE 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.
Brief Summary This study to will compare the blood levels of sildenafil following administration of an experimental tablet vs. the conventional oral tablet.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Erectile Dysfunction
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 19, 2009)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00866463
Other Study ID Numbers  ICMJE A1481265
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2013

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