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

Viatris

Status and phase: Completed; Phase 1

Conditions: Erectile Dysfunction

Treatments: Drug: Sildenafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01254396

A1481290

Details and patient eligibility

About

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

Enrollment: 12 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 Informed Consent.

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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12 participants in 2 patient groups

Sildenafil ODT tablet 50 mg, Fasted

Active Comparator group

Description:

Treatment A: Sildenafil ODT tablet 50 mg, administered without water under fasted conditions.

Treatment:

Drug: Sildenafil

Drug: Sildenafil

Sildenafil ODT tablet 50 mg, Fed

Experimental group

Description:

Treatment B: Sildenafil ODT tablet 50 mg, administered without water under fed conditions.

Treatment:

Drug: Sildenafil

Drug: Sildenafil