Study to Compare the Blood Levels of Sildenafil Following Administration of an Experimental Tablet vs. the Conventional Oral Tablet in Healthy Subjects.
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sildenafil
Sildenafil
Sildenafil
Sponsored by
About this trial
This is an interventional basic science trial for Erectile Dysfunction
Eligibility 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.
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Conventional Oral Tablet With Water
Experimental Tablet With Water
Experimental Tablet Without Water
Arm Description
Outcomes
Primary Outcome Measures
Blood levels of sildenafil
Secondary Outcome Measures
Blood levels of a metabolite of sildenafil
Safety
Full Information
NCT ID
NCT00795938
First Posted
November 19, 2008
Last Updated
January 28, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00795938
Brief Title
Study to Compare the Blood Levels of Sildenafil Following Administration of an Experimental Tablet vs. the Conventional Oral Tablet in Healthy Subjects.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study to will compare the blood levels of sildenafil following administration of an experimental tablet vs. the conventional oral tablet.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Oral Tablet With Water
Arm Type
Active Comparator
Arm Title
Experimental Tablet With Water
Arm Type
Experimental
Arm Title
Experimental Tablet Without Water
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sildenafil
Intervention Description
Single Dose of 50 mg Sildenafil Oral Tablet With Water
Intervention Type
Drug
Intervention Name(s)
Sildenafil
Intervention Description
Single Dose of 50 mg Sildenafil Experimental Tablet With Water
Intervention Type
Drug
Intervention Name(s)
Sildenafil
Intervention Description
Single Dose of 50 mg Sildenafil Experimental Tablet Without Water
Primary Outcome Measure Information:
Title
Blood levels of sildenafil
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Blood levels of a metabolite of sildenafil
Time Frame
1 day
Title
Safety
Time Frame
1 day
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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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