Bioavailability of 3 Sildenafil Oral Disintegrating Tablet Formulations Compared to the Standard Oral Tablet

Viatris

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Formulation C ODT tablet 50 mg; Drug: Formulation D ODT tablet 50 mg; Drug: Formulation B ODT tablet 50 mg; Drug: Viagra 50 mg tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00950404

A1481273

Details and patient eligibility

About

The bioavailability of the oral disintegrating tablet formulations given without water will be similar to an equivalent dose of the standard oral tablet given with water.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects
• Weight: BMI from 17.5 to 30.5

Exclusion criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• A positive urine drug screen.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 4 patient groups

Viagra 50 mg tablet, administered with water.

Active Comparator group

Treatment:

Drug: Viagra 50 mg tablet

Formulation B ODT tablet 50 mg, administered without water.

Experimental group

Treatment:

Drug: Formulation B ODT tablet 50 mg

Formulation C ODT tablet 50 mg, administered without water.

Experimental group

Treatment:

Drug: Formulation C ODT tablet 50 mg

Formulation D ODT tablet 50 mg, administered without water.

Experimental group

Treatment:

Drug: Formulation D ODT tablet 50 mg