Bioequivalence Study For Orally-Disintegrating Tablet Of Sildenafil

Study Overview
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Brief Summary
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The purpose of this study is to assess the bioequivalence of Sildenafil ODT 50 mg without water to Japanese commercial oral tablet of sildenafil citrate (Viagra® tablet) 50 mg under fasted conditions.

Official Title
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Phase 1, Open-Label, Randomized, Single-Dose, 3-Way Crossover Study Assessing Bioequivalence Of Sildenafil 50 Mg Orally-Disintegrating Tablet With Or Without Water To Viagra® 50 Mg Oral Tablet With Water Under Fasted Condition

Conditions
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Healthy

Intervention / Treatment
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* Drug: Viagra
* Drug: sildenafil ODT
* Drug: sildenafil ODT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Japanese male subjects between the ages of 20 and 55 years. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs). Exclusion Criteria: Baseline orthostatic hypotension defined as a >=20 mm Hg reduction in systolic blood pressure (SBP), a >=10 mm Hg reduction in diastolic blood pressure (DBP) or the development of significant postural symptoms (dizziness, lightheadedness, vertigo) when going from the supine to standing position. Subjects who are currently prescribed or taking nitrates or nitric oxide donors in any form on either a regular or intermittent basis.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 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: Viagra<br>Oral tablet of sildenafil citrate (Japanese commercial tablet: Viagra® tablet) 50 mg as a single oral dose under fasted conditions | Drug: Viagra<br>* 50 mg tablet on Day 1 of each period<br>* Other names: sildenafil citrate;|
| Experimental: ODT without water<br>Sildenafil ODT 50 mg without water as a single oral dose under fasted conditions | Drug: sildenafil ODT<br>* 50 mg tablet on Day 1 of each period<br>|
| Experimental: ODT with water<br>Sildenafil ODT 50 mg with water as a single oral dose under fasted conditions | Drug: sildenafil ODT<br>* 50 mg tablet on Day 1 of each period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] |  | 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose | 
| Maximum Observed Plasma Concentration (Cmax) |  | 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] |  | 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose | 
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |  | 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose | 
| Maximum Observed Plasma Concentration (Cmax) |  | 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose | 
| Plasma Decay Half-Life (t1/2) |  | 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose | 
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | 9 days | 
| Diastolic and Systolic Blood Pressure |  | 9 days | 
| 12-lead electrocardiogram (ECG) |  | 9 days | 
| Pulse rate (PR) |  | 9 days | 
| Number of Participants With Laboratory Test Values of Potential Clinical Importance |  | 9 days | 
| Mean Residence Time(MRT) |  | 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Viagra, ODT, bioquivalence