A Study to Compare the Blood Levels of Sildenafil Following Administration of an Experimental Tablet vs. the Conventional Oral Tablet in Healthy Subjects

Viatris

Status and phase: Completed; Phase 1

Conditions: Erectile Dysfunction

Treatments: Drug: Sildenafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00866463

A1481265

Details and patient eligibility

About

This study to will compare the blood levels of sildenafil following administration of an experimental tablet vs. the conventional oral tablet.

Enrollment: 18 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males between the ages of 18 and 55 years.
• Body Mass Index of 18 to 30 kg/m2, and a total body weight >50 kg (110 lbs).

Exclusion criteria

• Smoking in excess of the equivalent of 5 cigarettes per day.
• Treatment with an experimental drug within 30 days or sildenafil, vardenafil, tadalfil within 4 days before first study dose.
• Develop blood pressure lowering or experience dizziness, lightheadedness when going from the laying down position to standing position.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Conventional Oral Tablet With Water

Active Comparator group

Treatment:

Drug: Sildenafil

Drug: Sildenafil

Drug: Sildenafil

Experimental Tablet With Water

Experimental group

Treatment:

Drug: Sildenafil

Drug: Sildenafil

Drug: Sildenafil

Experimental Tablet Without Water

Experimental group

Treatment:

Drug: Sildenafil

Drug: Sildenafil

Drug: Sildenafil