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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00950404
First received: July 30, 2009
Last updated: October 5, 2009
Last verified: October 2009
  Purpose

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
Endpoint Classification: Bio-availability Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUC0-Tmax and AUCinf of sildenafil [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Tmax and half-life of sildenafil [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • vital signs [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • laboratory parameters [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT00950404

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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00950404     History of Changes
Other Study ID Numbers: A1481273
Study First Received: July 30, 2009
Last Updated: October 5, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Bioavailability Pharmacokinetic Formulation

Additional relevant MeSH terms:
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on September 22, 2014