Bioequivalence Study For Orally-Disintegrating Tablet Of Sildenafil

Viatris

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: sildenafil ODT; Drug: Viagra

Study type: Interventional

Funder types: Industry

Identifiers

NCT01737203

A1481315

Details and patient eligibility

About

The purpose of this study is to assess the bioequivalence of Sildenafil ODT 50 mg without water to Japanese commercial oral tablet of sildenafil citrate (Viagra® tablet) 50 mg under fasted conditions.

Enrollment: 53 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Japanese male subjects between the ages of 20 and 55 years.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion criteria

• Baseline orthostatic hypotension defined as a >=20 mm Hg reduction in systolic blood pressure (SBP), a >=10 mm Hg reduction in diastolic blood pressure (DBP) or the development of significant postural symptoms (dizziness, lightheadedness, vertigo) when going from the supine to standing position.
• Subjects who are currently prescribed or taking nitrates or nitric oxide donors in any form on either a regular or intermittent basis.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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53 participants in 3 patient groups

Viagra

Active Comparator group

Description:

Oral tablet of sildenafil citrate (Japanese commercial tablet: Viagra® tablet) 50 mg as a single oral dose under fasted conditions

Treatment:

Drug: Viagra

ODT without water

Experimental group

Description:

Sildenafil ODT 50 mg without water as a single oral dose under fasted conditions

Treatment:

Drug: sildenafil ODT

Drug: sildenafil ODT

ODT with water

Experimental group

Description:

Sildenafil ODT 50 mg with water as a single oral dose under fasted conditions

Treatment:

Drug: sildenafil ODT

Drug: sildenafil ODT