Study Of Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations

Viatris

Status and phase: Completed; Phase 4

Conditions: Healthy Males

Treatments: Drug: Treatment B; Drug: Treatment C; Other: Blood samples for the analysis of sildenafil in plasma; Drug: Treatment A

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00902512

A1481267

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Treatment A

Active Comparator group

Description:

Viagra® 100 mg tablet, administered with water

Treatment:

Drug: Treatment A

Treatment B

Active Comparator group

Description:

Sildenafil 100 mg CT administered with water

Treatment:

Other: Blood samples for the analysis of sildenafil in plasma

Drug: Treatment B

Other: Blood samples for the analysis of sildenafil in plasma

Other: Blood samples for the analysis of sildenafil in plasma

Treatment C

Active Comparator group

Description:

Sildenafil 100 mg CT administered without water

Treatment:

Other: Blood samples for the analysis of sildenafil in plasma

Drug: Treatment C

Other: Blood samples for the analysis of sildenafil in plasma

Other: Blood samples for the analysis of sildenafil in plasma