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Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Given With Or Without Food.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01254396
First Posted: December 6, 2010
Last Update Posted: February 8, 2012
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.
Information provided by (Responsible Party):
Pfizer
  Purpose
This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties when given with food and without food.

Condition Intervention Phase
Erectile Dysfunction Drug: Sildenafil Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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 An Orally Disintegrating Tablet Formulation Of Sildenafil Administered Without Water Under Fed Compared To Fasted Conditions

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hours (hrs) post-dose ]
    Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).


Secondary Outcome Measures:
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose ]
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] [ Time Frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose ]
    AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).

  • Plasma Decay Half Life (t1/2) [ Time Frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.


Enrollment: 12
Study Start Date: December 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sildenafil ODT tablet 50 mg, Fasted
Treatment A: Sildenafil ODT tablet 50 mg, administered without water under fasted conditions.
Drug: Sildenafil
Orally Disintegrating Tablet, 50 mg, Single Dose
Experimental: Sildenafil ODT tablet 50 mg, Fed
Treatment B: Sildenafil ODT tablet 50 mg, administered without water under fed conditions.
Drug: Sildenafil
Orally Disintegrating Tablet, 50 mg, Single Dose

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes 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 Informed Consent.

Exclusion Criteria:

  • Evidence or history of clinically significant abnormalities
  • Have baseline orthostatic hypotension
  • Positive drug screen, excessive alcohol and tobacco use
  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): NCT01254396


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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01254396     History of Changes
Other Study ID Numbers: A1481290
First Submitted: November 19, 2010
First Posted: December 6, 2010
Results First Submitted: January 7, 2012
Results First Posted: February 8, 2012
Last Update Posted: February 8, 2012
Last Verified: January 2012

Keywords provided by Pfizer:
Bioavailability Food Effect Oral Dissolving Tablet (ODT)

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents