Status:

COMPLETED

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

Lead Sponsor:

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

Conditions:

Erectile Dysfunction

Eligibility:

MALE

18-55 years

Phase:

PHASE1

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

October 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2008

Estimated Enrollment :

18 Patients enrolled

Trial Details

Trial ID

NCT00795938

Start Date

October 1 2008

End Date

November 1 2008

Last Update

February 1 2021

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Pfizer Investigational Site

New Haven, Connecticut, United States, 06511