A Relative Bioavailability Study of Revatio for the Crushed Tablets, Extemporaneously Prepared Formulation, and the Intact Tablets at 20 mg Dose in Healthy Volunteers

Study Overview
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Brief Summary
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This will be a randomized, open-label, 3-treatment, 3-period, crossover, single-dose study in healthy subjects. Eighteen (18) subjects will complete the study; dropouts may be replaced at the discretion of the sponsor. Three treatments are: Treatment A: Revatio 20 mg intact tablet. Treatment B: Revatio 20 mg crushed tablet mixed with apple sauce. Treatment C: Revatio 20 mg extemporaneously prepared suspension (EP). Blood samples for the analysis of sildenafil in plasma will be obtained pre-dose and up to 14 hours post dose in each period. Tolerability and safety will be assessed by reported adverse events during each study period.

Official Title
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A Randomised, Open-Label 3-Way Crossover Study To Investigate The Relative Bioavailability Of The Crushed Revatio 20 Mg Tablet Mixed With Apple Sauce, The Extemporaneously Prepared Suspension (EP), And The Intact Revatio 20 Mg Tablet In Healthy Volunteers Under Fasting Conditions

Conditions
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Healthy

Intervention / Treatment
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* Drug: Revatio
* Drug: Revatio
* Drug: Revatio


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs). An informed consent document signed and dated by the subject or a legally acceptable representative. Subjects who are willing and able to comply with 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 time of dosing) disease or clinical findings at Screening. History of febrile illness within 5 days prior to the first dose. Any condition possibly affecting drug absorption (eg, gastrectomy). 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment A<br>Revatio 20 mg intact tablet. This is the reference treatment arm. | Drug: Revatio<br>* Three treatments as described in study design, single dose, three way crossover. The treatment duration will be minimum 3 days for each subject.<br>|
| Experimental: Treatment B<br>Treatment B: Revatio 20 mg crushed tablet mixed with apple sauce. | Drug: Revatio<br>* Three treatments as described in study design, single dose, three way crossover. The treatment duration will be minimum 3 days for each subject.<br>|
| Experimental: Treatment C<br>Treatment C: Revatio 20 mg extemporaneously prepared suspension (EP). | Drug: Revatio<br>* Three treatments as described in study design, single dose, three way crossover. The treatment duration will be minimum 3 days for each subject.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast |  | Within 14 hours post dose | 
| Cmax |  | Within 14 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T1/2 |  | Within 14 hours post dose | 
| AUCinf |  | Within 14 hours post dose | 
| Tmax |  | Within 14 hours post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioavailability, Revatio, Healthy Volunteers