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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2008-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Conventional Oral Tablet With Water

Group Type ACTIVE_COMPARATOR

Sildenafil

Intervention Type DRUG

Single Dose of 50 mg Sildenafil Oral Tablet With Water

Experimental Tablet With Water

Group Type EXPERIMENTAL

Sildenafil

Intervention Type DRUG

Single Dose of 50 mg Sildenafil Experimental Tablet With Water

Experimental Tablet Without Water

Group Type EXPERIMENTAL

Sildenafil

Intervention Type DRUG

Single Dose of 50 mg Sildenafil Experimental Tablet Without Water

Interventions

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Sildenafil

Single Dose of 50 mg Sildenafil Oral Tablet With Water

Intervention Type DRUG

Sildenafil

Single Dose of 50 mg Sildenafil Experimental Tablet With Water

Intervention Type DRUG

Sildenafil

Single Dose of 50 mg Sildenafil Experimental Tablet Without Water

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes