Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Given With Or Without Food.

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

Overview

This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties when given with food and without food.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Erectile Dysfunction

Interventions

SildenafilDRUG

Orally Disintegrating Tablet, 50 mg, Single Dose

SildenafilDRUG

Orally Disintegrating Tablet, 50 mg, Single Dose

Eligibility

Sex: MALEMin age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Otherwise healthy male subjects age 45 years or older with or without erectile dysfunction. * Body Mass Index (BMI) of 17.5 to 32.5 kg/m2. * Signed Informed Consent. Exclusion Criteria: * Evidence or history of clinically significant abnormalities * Have baseline orthostatic hypotension * Positive drug screen, excessive alcohol and tobacco use

Locations (1)

Pfizer Investigational Site

Singapore, Singapore

Outcomes

Primary Outcomes

Maximum Observed Plasma Concentration (Cmax)

Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).

Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hours (hrs) post-dose

Secondary Outcomes

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]

AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).

Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose

Plasma Decay Half Life (t1/2)

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose

Data from ClinicalTrials.gov

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