NCT00866463

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2009

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

Same day

First QC Date

March 19, 2009

Last Update Submit

January 28, 2021

Conditions

Erectile Dysfunction

Keywords

Sildenafil, Pharmacokinetics, Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

  • Blood levels of sildenafil

    1 Day

Secondary Outcomes (2)

  • Blood levels of a metabolite of sildenafil

    1 Day

  • Side Effects

    1 Day

Study Arms (3)

Conventional Oral Tablet With Water

ACTIVE COMPARATOR
Drug: Sildenafil

Experimental Tablet With Water

EXPERIMENTAL
Drug: Sildenafil

Experimental Tablet Without Water

EXPERIMENTAL
Drug: Sildenafil

Interventions

SildenafilDRUG

Single Dose of 50 mg Sildenafil Oral Tablet With Water

Conventional Oral Tablet With Water

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2009

First Posted

March 20, 2009

Study Start

October 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

February 1, 2021

Record last verified: 2021-01

Locations

US(1)