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

Study Overview
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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.

Official Title
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An Open-Label, Crossover Study In Healthy Volunteers To Evaluate The Pharmacokinetics Of Sildenafil Following Administration Of Three Orally Disintegrating Tablet Formulations Of Sildenafil Without Water Relative To Viagra Conventional Oral Tablet With Water.

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Viagra 50 mg tablet
* Drug: Formulation B ODT tablet 50 mg
* Drug: Formulation C ODT tablet 50 mg
* Drug: Formulation D ODT tablet 50 mg


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Viagra 50 mg tablet, administered with water.<br> | Drug: Viagra 50 mg tablet<br>* Commercial tablet, 50 mg, single dose administered with water<br>|
| Experimental: Formulation B ODT tablet 50 mg, administered without water.<br> | Drug: Formulation B ODT tablet 50 mg<br>* Oral disintegrating tablet (ODT), 50 mg, single dose administered without water<br>|
| Experimental: Formulation C ODT tablet 50 mg, administered without water.<br> | Drug: Formulation C ODT tablet 50 mg<br>* ODT, 50 mg, single dose administered without water<br>|
| Experimental: Formulation D ODT tablet 50 mg, administered without water.<br> | Drug: Formulation D ODT tablet 50 mg<br>* ODT, 50 mg, single dose, administered without water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-T and Cmax of sildenafil |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-Tmax and AUCinf of sildenafil |  | 1 month | 
| Tmax and half-life of sildenafil |  | 1 month | 
| adverse events |  | 3 weeks | 
| vital signs |  | 3 weeks | 
| laboratory parameters |  | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioavailability Pharmacokinetic Formulation