Study Of Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations

Study Overview
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Brief Summary
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the pharmacokinetics of sildenafil following single doses of sildenafil CT administered with and without water is similar relative to the conventional oral tablet of sildenafil administered with water.

Official Title
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Relative Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations In Healthy Volunteers Under Fasting Conditions.

Conditions
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Healthy Males

Intervention / Treatment
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* Drug: Treatment A
* Drug: Blood samples for the analysis of sildenafil in plasma
* Drug: Treatment B
* Other: Blood samples for the analysis of sildenafil in plasma
* Drug: Treatment C
* Other: Blood samples for the analysis of sildenafil in plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Only healthy male volunteers in the 18-40 age range will be included. At the selection visit allowed normal range for vital signs will be: Blood pressure (with the subject sitting down) 90-130mm Hg systolic and 60-90 The volunteers' health condition will be determined from their complete clinical history by doctors at the clinical research site and lab test results by certified clinical laboratories mm Hg diastolic, heart rate 55-100 bpm , respiratory rate 14-20 respirations per minute. Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening. Treatment with a PDE-5 inhibitor within the 4 days preceding the first dose of study medication History of hypersensitivity to sildenafil citrate or any components of its formulations

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment A<br>Viagra® 100 mg tablet, administered with water | Drug: Treatment A<br>* Viagra® 100 mg tablet, administered with water single dose<br>Drug: Blood samples for the analysis of sildenafil in plasma<br>* Blood samples for the analysis of sildenafil in plasma<br>|
| Active Comparator: Treatment B<br>Sildenafil 100 mg CT administered with water | Drug: Treatment B<br>* Sildenafil 100 mg CT administered with water single dose<br>Other: Blood samples for the analysis of sildenafil in plasma<br>* Blood samples for the analysis of sildenafil in plasma<br>|
| Active Comparator: Treatment C<br>Sildenafil 100 mg CT administered without water | Drug: Treatment C<br>* Sildenafil 100 mg CT administered without water single dose<br>Other: Blood samples for the analysis of sildenafil in plasma<br>* Blood samples for the analysis of sildenafil in plasma<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 |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-inf of sildenafil |  | 28 days | 
| Tmax and half-life of sildenafil |  | 28 days | 
| Adverse events and vital signs |  | 28 days |