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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00950404
Recruitment Status : Completed
First Posted : July 31, 2009
Last Update Posted : October 7, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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.
Study Start Date : August 2009
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00950404     History of Changes
Other Study ID Numbers: A1481273
First Posted: July 31, 2009    Key Record Dates
Last Update Posted: October 7, 2009
Last Verified: October 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