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

Viatris

Status and phase: Completed; Phase 1

Conditions: Erectile Dysfunction

Treatments: Drug: Sildenafil ODT; Drug: Sildenafil Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT01254383

A1481289

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: Male

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Treatment A

Active Comparator group

Description:

Viagra 50 mg tablet, administered with approximately 240 mL water under fasted conditions

Treatment:

Drug: Sildenafil Tablet

Treatment B

Experimental group

Description:

Sildenafil ODT tablet 50 mg, administered without water under fasted conditions

Treatment:

Drug: Sildenafil ODT

Drug: Sildenafil ODT

Treatment C

Experimental group

Description:

Sildenafil ODT tablet 50 mg, administered with water under fasted conditions.

Treatment:

Drug: Sildenafil ODT

Drug: Sildenafil ODT