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OpenTrials
Completed

NCT Number: NCT00866463

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

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

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sildenafil

Drug

Single Dose of 50 mg Sildenafil Oral Tablet With Water

Primary outcomes

  1. Blood levels of sildenafil

    Time frame: 1 Day

Secondary outcomes

  1. Blood levels of a metabolite of sildenafil

    Time frame: 1 Day

  2. Side Effects

    Time frame: 1 Day

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 20, 2009
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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