Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Versus To Viagra® Oral Tablet.

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-03-31

Brief Summary

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This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties as the conventional tablet of sildenafil.

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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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Treatment A

Viagra 50 mg tablet, administered with approximately 240 mL water under fasted conditions

Group Type ACTIVE_COMPARATOR

Sildenafil Tablet

Intervention Type DRUG

Tablet, 50 mg, Single Dose

Treatment B

Sildenafil ODT tablet 50 mg, administered without water under fasted conditions

Group Type EXPERIMENTAL

Sildenafil ODT

Intervention Type DRUG

Orally Disintegrating Tablet, 50 mg, Single Dose

Treatment C

Sildenafil ODT tablet 50 mg, administered with water under fasted conditions.

Group Type EXPERIMENTAL

Sildenafil ODT

Intervention Type DRUG

Orally Disintegrating Tablet, 50 mg, Single Dose

Interventions

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Sildenafil Tablet

Tablet, 50 mg, Single Dose

Intervention Type DRUG

Sildenafil ODT

Orally Disintegrating Tablet, 50 mg, Single Dose

Intervention Type DRUG

Sildenafil ODT

Orally Disintegrating Tablet, 50 mg, Single Dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Otherwise healthy male subjects age 45 years or older with or without erectile dysfunction.

Body Mass Index (BMI) of 17.5 to 32.5 kg/m2.

Signed and dated informed consent document.

Exclusion Criteria

* Evidence or history of clinically significant abnormalities
* Have baseline orthostatic hypotension
* Positive drug screen, excessive alcohol and tobacco use

Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes