Bioavailability of 3 Sildenafil Oral Disintegrating Tablet Formulations Compared to the Standard 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

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-09-30

Brief Summary

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The bioavailability of the oral disintegrating tablet formulations given without water will be similar to an equivalent dose of the standard oral tablet given with water.

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Detailed Description

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Conditions

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Healthy Volunteers

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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Viagra 50 mg tablet, administered with water.

Group Type ACTIVE_COMPARATOR

Viagra 50 mg tablet

Intervention Type DRUG

Commercial tablet, 50 mg, single dose administered with water

Formulation B ODT tablet 50 mg, administered without water.

Group Type EXPERIMENTAL

Formulation B ODT tablet 50 mg

Intervention Type DRUG

Oral disintegrating tablet (ODT), 50 mg, single dose administered without water

Formulation C ODT tablet 50 mg, administered without water.

Group Type EXPERIMENTAL

Formulation C ODT tablet 50 mg

Intervention Type DRUG

ODT, 50 mg, single dose administered without water

Formulation D ODT tablet 50 mg, administered without water.

Group Type EXPERIMENTAL

Formulation D ODT tablet 50 mg

Intervention Type DRUG

ODT, 50 mg, single dose, administered without water

Interventions

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Viagra 50 mg tablet

Commercial tablet, 50 mg, single dose administered with water

Intervention Type DRUG

Formulation B ODT tablet 50 mg

Oral disintegrating tablet (ODT), 50 mg, single dose administered without water

Intervention Type DRUG

Formulation C ODT tablet 50 mg

ODT, 50 mg, single dose administered without water

Intervention Type DRUG

Formulation D ODT tablet 50 mg

ODT, 50 mg, single dose, administered without water

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects
* Weight: BMI from 17.5 to 30.5

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes