Food Effect Study For New Formulation

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.12 enrolled

Overview

The main objective of this study is to estimate the effect of food on sildenafil pharmacokinetics after administration of Powder Oral Suspension (POS) formulation of sildenafil citrate.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

sildenafil citrateDRUG

2 mL of POS formulation of sildenafil citrate 10 mg/mL (equivalent to 20 mg dose), single dose

sildenafil citrateDRUG

2 mL of POS formulation of sildenafil citrate 10 mg/mL (equivalent to 20 mg dose), single dose

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male and/or female subjects between the ages of 21 and 55 years * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>45 kg (99 lbs). Exclusion Criteria: * Baseline orthostatic hypotension defined as a ≥20 mm Hg reduction in systolic blood pressure (SBP), a ≥10 mm Hg reduction in diastolic blood pressure (DBP) or the development of significant postural symptoms (dizziness, lightheadedness, vertigo) when going from the supine to standing position. * Subjects who are currently prescribed and/or taking nitrates or nitric oxide donors in any form on either a regular or intermittent basis.

Locations (1)

Pfizer Investigational Site

Singapore, Singapore