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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

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sildenafil
Sildenafil
Sildenafil
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Erectile Dysfunction focused on measuring Sildenafil, Pharmacokinetics, Healthy Volunteer

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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
Side Effects

Full Information

First Posted
March 19, 2009
Last Updated
January 28, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00866463
Brief Title
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
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
October 2008 (Actual)
Study Completion Date
October 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
Keywords
Sildenafil, Pharmacokinetics, Healthy Volunteer

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
Side Effects
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

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481265&StudyName=A%20Study%20to%20Compare%20the%20Blood%20Levels%20of%20Sildenafil%20Following%20Administration%20of%20an%20Experimental%20Tablet%20vs.%20the%20Conventional%20Oral%20Tablet%20
Description
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Learn more about this trial

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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