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OpenTrials
Completed

NCT Number: NCT01254396

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

This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties when given with food and without food.

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Singapore, 188770

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sildenafil

Drug

Orally Disintegrating Tablet, 50 mg, Single Dose

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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

  2. 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-∞).

  3. 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.

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 6, 2010
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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