A Pivotal Bioequivalence Study Between The Sildenafil Powder For Oral Suspension (10 Mg/Ml) And The Sildenafil 10 Mg Immediate Release (IR) Tablet Relative To The Revatio 20 Mg IR Tablet In Healthy Volunteers Under Fasting Conditions

Study Overview
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Brief Summary
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The hypothesis for the trial is that the Sildenafil Citrate Powder for Oral Suspension (10 Mg/ml) bioequivalent to the Revatio 20 Mg IR tablet in Healthy Volunteers and the Sildenafil Citrate 10 Mg immediate release (IR) tablet is bioequivalent to the Revatio 20 Mg IR tablet in Healthy Volunteers.

Official Title
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A Pivotal Randomised, Open-Label 3-Way Crossover Study To Demonstrate Bioequivalence Of The Sildenafil Citrate Powder For Oral Suspension (10 Mg/Ml) And The Sildenafil Citrate 10 Mg Immediate Release (IR) Tablet Relative To The Revatio 20 Mg IR Tablet In Healthy Volunteers Under Fasting Conditions

Conditions
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Pulmonary Arterial Hypertention

Intervention / Treatment
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* Drug: sildenafil citrate
* Drug: Sildenafil citrate
* Drug: sildenafil citrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) Healthy male/female subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests. 2. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs). 3. An informed consent document signed and dated by the subject or a legally acceptable representative. 4. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, ocular or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) disease or clinical findings at Screening. History of febrile illness within 5 days prior to the first dose. 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>Revatio: 1 x 20 mg IR oral tablet. | Drug: sildenafil citrate<br>* Single oral dose of 1 x 20 mg IR oral tablet.<br>* Other names: Revatio;|
| Experimental: Treatment B<br>2 x 10 mg sildenafil citrate IR oral tablet. | Drug: Sildenafil citrate<br>* single oral dose of 2 x 10 mg sildenafil citrate IR oral tablet.<br>* Other names: Revatio;|
| Experimental: Treatment C<br>2 mL of the 10 mg/mL sildenafil citrate POS (20 mg dose). | Drug: sildenafil citrate<br>* single oral dose of 2 mL of the 10 mg/mL sildenafil citrate POS (20 mg dose).<br>* Other names: Revatio;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC0-T) of sildenafil plasma concentrations from time zero to the time T of last measurable concentration. |  | Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose | 
| Maximum sildenafil plasma concentration (Cmax) |  | Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf, AUC of sildenafil from time zero to time infinity. AUCinf = AUC0-T+AUCextrapolated |  | Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose | 
| AUC%extrapolated of sildenafil. |  | Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose | 
| Tmax - time at which maximum sildenafil plasma concentration occurs |  | Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose | 
| Adverse events |  | From FSFV to LSLV, up to 5 weeks | 
| terminal half-life of sildenafil. |  | Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Powder for oral suspention