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Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Versus To Viagra® Oral Tablet.

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01254383
First received: November 19, 2010
Last updated: June 7, 2011
Last verified: June 2011
History of Changes
  Purpose

This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties as the conventional tablet of sildenafil.


Condition Intervention Phase
Erectile Dysfunction
 Drug: Sildenafil Tablet
Drug: Sildenafil ODT
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open Label Crossover Study In Healthy Older Male Subjects To Evaluate The Pharmacokinetics And Safety Of Sildenafil Following Fasted Administration Of An Orally Disintegrating Tablet Formulation Of Sildenafil Administered With Or Without Water Relative To Viagra® Oral Tablet With Water

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • AUC(0-t) of sildenafil. [ Time Frame: Up to 1 month ] [ Designated as safety issue: No ]
  • Cmax of sildenafil. [ Time Frame: Up to 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUC(0-inf) of sildenafil, if data permits. [ Time Frame: Up to 1 month ] [ Designated as safety issue: No ]
  • Half-life of sildenafil, if data permits. [ Time Frame: Up to 1 month ] [ Designated as safety issue: No ]
  • Tmax of sildenafil. [ Time Frame: Up to 1 month ] [ Designated as safety issue: No ]
  • Number of patients with adverse events. [ Time Frame: Up to 1 month ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: December 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment A
Viagra 50 mg tablet, administered with approximately 240 mL water under fasted conditions
 Drug: Sildenafil Tablet
Tablet, 50 mg, Single Dose
Experimental: Treatment B
Sildenafil ODT tablet 50 mg, administered without water under fasted conditions
 Drug: Sildenafil ODT
Orally Disintegrating Tablet, 50 mg, Single Dose
Experimental: Treatment C
Sildenafil ODT tablet 50 mg, administered with water under fasted conditions.
 Drug: Sildenafil ODT
Orally Disintegrating Tablet, 50 mg, Single Dose

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Otherwise healthy male subjects age 45 years or older with or without erectile dysfunction.

Body Mass Index (BMI) of 17.5 to 32.5 kg/m2.

Signed and dated informed consent document.

Exclusion Criteria:

  • Evidence or history of clinically significant abnormalities
  • Have baseline orthostatic hypotension
  • Positive drug screen, excessive alcohol and tobacco use
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254383

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01254383     History of Changes
Other Study ID Numbers: A1481289
Study First Received: November 19, 2010
Last Updated: June 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Bioequivalence Oral Dissolving Tablet

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Sildenafil
Vasodilator Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013