Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Versus To Viagra® Oral Tablet.

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.36 enrolled

Overview

This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties as the conventional tablet of sildenafil.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Erectile Dysfunction

Interventions

Sildenafil TabletDRUG

Tablet, 50 mg, Single Dose

Sildenafil ODTDRUG

Orally Disintegrating Tablet, 50 mg, Single Dose

Sildenafil ODTDRUG

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 and dated informed consent document. 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

AUC(0-t) of sildenafil.

Time frame: Up to 1 month

Cmax of sildenafil.

Time frame: Up to 1 month

Secondary Outcomes

AUC(0-inf) of sildenafil, if data permits.

Time frame: Up to 1 month

Half-life of sildenafil, if data permits.

Time frame: Up to 1 month

Tmax of sildenafil.

Time frame: Up to 1 month

Number of patients with adverse events.

Time frame: Up to 1 month

Data from ClinicalTrials.gov

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