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NCT00866463 Clinical Trial

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

Erectile Dysfunction Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00866463
Other study ID # A1481265
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 2008
Est. completion date October 2008

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study to will compare the blood levels of sildenafil following administration of an experimental tablet vs. the conventional oral tablet.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Sildenafil
Single Dose of 50 mg Sildenafil Oral Tablet With Water
• Sildenafil
Single Dose of 50 mg Sildenafil Experimental Tablet With Water
• Sildenafil
Single Dose of 50 mg Sildenafil Experimental Tablet Without Water

Locations
Country Name City State
United States Pfizer Investigational Site New Haven Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood levels of sildenafil 1 Day
Secondary Blood levels of a metabolite of sildenafil 1 Day
Secondary Side Effects 1 Day
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