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Healthy Males

Study Of Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations

Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

About this trial

Last updated 5 years ago

Study ID

A1481267

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18-75 Years
18 to 40 Years
Male
Male

Trial Timing

Ended 16 years ago

What is this trial 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.

What are the participation requirements?

Yes

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.

No

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