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OpenTrials
Completed

NCT Number: NCT00950404

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Viagra 50 mg tablet

Drug

Commercial tablet, 50 mg, single dose administered with water

Formulation B ODT tablet 50 mg

Drug

Oral disintegrating tablet (ODT), 50 mg, single dose administered without water

Formulation C ODT tablet 50 mg

Drug

ODT, 50 mg, single dose administered without water

Formulation D ODT tablet 50 mg

Drug

ODT, 50 mg, single dose, administered without water

Primary outcomes

  1. AUC0-T and Cmax of sildenafil

    Time frame: 1 month

Secondary outcomes

  1. AUC0-Tmax and AUCinf of sildenafil

    Time frame: 1 month

  2. Tmax and half-life of sildenafil

    Time frame: 1 month

  3. adverse events

    Time frame: 3 weeks

  4. vital signs

    Time frame: 3 weeks

  5. laboratory parameters

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

An Open-Label, Crossover Study In Healthy Volunteers To Evaluate The Pharmacokinetics Of Sildenafil Following Administration Of Three Orally Disintegrating Tablet Formulations Of Sildenafil Without Water Relative To Viagra Conventional Oral Tablet With Water.

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 31, 2009
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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