CompletedNCT00866463Updated Feb 1, 2021

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

A Phase 1 interventional study of Sildenafil and Sildenafil in Erectile Dysfunction, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-01.

Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 18
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: Male

Study summary

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

Conditions studied

Erectile Dysfunction

Browse trials for

Erectile Dysfunction 683

Keywords

Sildenafil, Pharmacokinetics, Healthy Volunteer

In context

Erectile Dysfunction

683 studies on the registry are indexed under Erectile Dysfunction; 117 are open to participants now.

This study's enrollment of 18 is below the median of 72 across 542 interventional studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

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

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

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 18 participants (actual)

Study arms

Active comparator
Conventional Oral Tablet With Water
Drug: Sildenafil
Experimental
Experimental Tablet With Water
Drug: Sildenafil
Experimental
Experimental Tablet Without Water
Drug: Sildenafil

Interventions

DrugSildenafil
Single Dose of 50 mg Sildenafil Oral Tablet With Water
DrugSildenafil
Single Dose of 50 mg Sildenafil Experimental Tablet With Water
DrugSildenafil
Single Dose of 50 mg Sildenafil Experimental Tablet Without Water

What researchers measure

Primary outcomes

Blood levels of sildenafil
Time frame: 1 Day

Secondary outcomes

Blood levels of a metabolite of sildenafil
Time frame: 1 Day
Side Effects
Time frame: 1 Day

Study locations

1 site

Pfizer Investigational Site
New Haven, Connecticut 06511, United States

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00866463
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Responsible party: Sponsor
First posted: Mar 20, 2009
Start date: Oct 2008
Primary completion: Oct 2008
Completion: Oct 2008
Last update: Feb 1, 2021

Study contacts

Pfizer CT.gov Call Center

study director · Pfizer

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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