Bioequivalence Study For Orally-Disintegrating Tablet Of Sildenafil

NCT01737203 | Completed Phase 1

• 1 other identifier: A1481315
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Viagra; ODT; bioquivalence

Outcome Measures

Primary Outcomes (2)

• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]

  0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose

• Maximum Observed Plasma Concentration (Cmax)

  0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose

Secondary Outcomes (11)

• Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]

  0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

  0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose

• Maximum Observed Plasma Concentration (Cmax)

  0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose

• Plasma Decay Half-Life (t1/2)

  0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose

Study Arms (3)

Viagra

ACTIVE COMPARATOR

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

Drug: Viagra

ODT without water

EXPERIMENTAL

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

Drug: sildenafil ODT

ODT with water

EXPERIMENTAL

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

Drug: sildenafil ODT

Interventions

Viagra DRUG

50 mg tablet on Day 1 of each period

Also known as: sildenafil citrate

Viagra

sildenafil ODT DRUG

50 mg tablet on Day 1 of each period

ODT without water

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (1)

Pfizer Investigational Site

Minato-ku, Tokyo, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Sildenafil Citrate

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2012
• First Posted: November 29, 2012
• Study Start: August 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: January 28, 2021

Record last verified: 2021-01

Locations

JP (1)