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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: July 30, 2009
Last updated: October 5, 2009
Last verified: October 2009
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.

Condition Intervention Phase
Healthy Volunteers
Drug: Viagra 50 mg tablet
Drug: Formulation B ODT tablet 50 mg
Drug: Formulation C ODT tablet 50 mg
Drug: Formulation D ODT tablet 50 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official 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.

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • AUC0-T and Cmax of sildenafil [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • AUC0-Tmax and AUCinf of sildenafil [ Time Frame: 1 month ]
  • Tmax and half-life of sildenafil [ Time Frame: 1 month ]
  • adverse events [ Time Frame: 3 weeks ]
  • vital signs [ Time Frame: 3 weeks ]
  • laboratory parameters [ Time Frame: 3 weeks ]

Estimated Enrollment: 16
Study Start Date: August 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Viagra 50 mg tablet, administered with water. Drug: Viagra 50 mg tablet
Commercial tablet, 50 mg, single dose administered with water
Experimental: Formulation B ODT tablet 50 mg, administered without water. Drug: Formulation B ODT tablet 50 mg
Oral disintegrating tablet (ODT), 50 mg, single dose administered without water
Experimental: Formulation C ODT tablet 50 mg, administered without water. Drug: Formulation C ODT tablet 50 mg
ODT, 50 mg, single dose administered without water
Experimental: Formulation D ODT tablet 50 mg, administered without water. Drug: Formulation D ODT tablet 50 mg
ODT, 50 mg, single dose, administered without water


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00950404

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00950404     History of Changes
Other Study ID Numbers: A1481273
Study First Received: July 30, 2009
Last Updated: October 5, 2009

Keywords provided by Pfizer:
Bioavailability Pharmacokinetic Formulation

Additional relevant MeSH terms:
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents processed this record on May 25, 2017