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.
1 other identifier
interventional
18
1 country
1
Brief Summary
This study to will compare the blood levels of sildenafil following administration of an experimental tablet vs. the conventional oral tablet.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2008
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 19, 2008
CompletedFirst Posted
Study publicly available on registry
November 21, 2008
CompletedFebruary 1, 2021
January 1, 2021
1 month
November 19, 2008
January 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Blood levels of sildenafil
1 day
Secondary Outcomes (2)
Blood levels of a metabolite of sildenafil
1 day
Safety
1 day
Study Arms (3)
Conventional Oral Tablet With Water
ACTIVE COMPARATORExperimental Tablet With Water
EXPERIMENTALExperimental Tablet Without Water
EXPERIMENTALInterventions
Single Dose of 50 mg Sildenafil Oral Tablet With Water
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2008
First Posted
November 21, 2008
Study Start
October 1, 2008
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
February 1, 2021
Record last verified: 2021-01