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

Last updated on December 6, 2018

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Study Location
Pfizer Investigational Site
Singapore, , 188770 Singapore
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Erectile Dysfunction
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Evidence or history of clinically significant abnormalities

- Have baseline orthostatic hypotension

- Positive drug screen, excessive alcohol and tobacco use

NCT01254396
Pfizer
Completed
Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Given With Or Without Food.

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Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Given With Or Without Food.
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
This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties when given with food and without food.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Erectile Dysfunction
Drug: Sildenafil
Orally Disintegrating Tablet, 50 mg, Single Dose
  • Active Comparator: Sildenafil ODT tablet 50 mg, Fasted
    Treatment A: Sildenafil ODT tablet 50 mg, administered without water under fasted conditions.
    Intervention: Drug: Sildenafil
  • Experimental: Sildenafil ODT tablet 50 mg, Fed
    Treatment B: Sildenafil ODT tablet 50 mg, administered without water under fed conditions.
    Intervention: Drug: Sildenafil
Damle B, Duczynski G, Jeffers BW, Crownover P, Coupe A, LaBadie RR. Pharmacokinetics of a novel orodispersible tablet of sildenafil in healthy subjects. Clin Ther. 2014 Feb 1;36(2):236-44. doi: 10.1016/j.clinthera.2013.12.010. Epub 2014 Jan 18.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
January 2011
January 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
45 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
 
NCT01254396
A1481290
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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