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

Phase 1

Completed

• Conditions: Erectile Dysfunction
• Interventions: Drug: Sildenafil

• Registration Number: NCT00866463
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Study First Submitted: 2009-03-19
• Study First Submitted QC: 2009-03-19
• Study First Posted: 2009-03-20
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Conventional Oral Tablet With Water	Sildenafil	-
Experimental Tablet With Water	Sildenafil	-
Experimental Tablet Without Water	Sildenafil	-

Primary Outcome Measures

Name	Time	Method
Blood levels of sildenafil	1 Day

Secondary Outcome Measures

Name	Time	Method
Blood levels of a metabolite of sildenafil	1 Day
Side Effects	1 Day

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States