Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Given With Or Without Food.

Study Overview
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Brief Summary
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This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties when given with food and without food.

Official Title
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An Open Label Crossover Study In Healthy Older Male Subjects To Evaluate The Pharmacokinetics And Safety Of An Orally Disintegrating Tablet Formulation Of Sildenafil Administered Without Water Under Fed Compared To Fasted Conditions

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Drug: Sildenafil
* Drug: Sildenafil


Participation Criteria
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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 Informed Consent. Exclusion Criteria: Evidence or history of clinically significant abnormalities Have baseline orthostatic hypotension Positive drug screen, excessive alcohol and tobacco use

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Male

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: Sildenafil ODT tablet 50 mg, Fasted<br>Treatment A: Sildenafil ODT tablet 50 mg, administered without water under fasted conditions. | Drug: Sildenafil<br>* Orally Disintegrating Tablet, 50 mg, Single Dose<br>|
| Experimental: Sildenafil ODT tablet 50 mg, Fed<br>Treatment B: Sildenafil ODT tablet 50 mg, administered without water under fed conditions. | Drug: Sildenafil<br>* Orally Disintegrating Tablet, 50 mg, Single Dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) |  | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose | 
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast). | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hours (hrs) post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose | 
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] | AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞). | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose | 
| Plasma Decay Half Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioavailability Food Effect Oral Dissolving Tablet (ODT)