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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

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NCT00866463

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Erectile Dysfunction
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00866463
Pfizer
Completed
A Study to Compare the Blood Levels of Sildenafil Following Administration of an Experimental Tablet vs. the Conventional Oral Tablet in Healthy Subjects

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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
NCT00866463
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New Haven, Connecticut
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
Intervention Model: Crossover Assignment
Masking: None (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.
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00866463
A1481265
No
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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[email protected]



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