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Food Effect Study For New Formulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01656798
First received: August 1, 2012
Last updated: September 14, 2012
Last verified: September 2012
History of Changes
  Purpose

The main objective of this study is to estimate the effect of food on sildenafil pharmacokinetics after administration of Powder Oral Suspension (POS) formulation of sildenafil citrate.


Condition Intervention Phase
Healthy
 Drug: sildenafil citrate
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open-Label, Randomized, Single-Dose, 2-Way Crossover Study In Healthy Subjects Assessing The Pharmacokinetics And Safety Of Powder For Oral Suspension Of Sildenafil Citrate Administered Under Fasted And Fed Conditions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Maximum Observed Plasma Concentration (Cmax) of sildenafil [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of sildenafil [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of sildenafil [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax)of sildenafil [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life (t1/2) of sildenafil [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) of UK-103,320 [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of UK-103,320 [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of UK-103,320 [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of UK-103,320 [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life (t1/2) of UK-103,320 [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: August 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fasted condition Drug: sildenafil citrate
2 mL of POS formulation of sildenafil citrate 10 mg/mL (equivalent to 20 mg dose), single dose
Experimental: fec condition Drug: sildenafil citrate
2 mL of POS formulation of sildenafil citrate 10 mg/mL (equivalent to 20 mg dose), single dose

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 21 and 55 years
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg (99 lbs).

Exclusion Criteria:

  • Baseline orthostatic hypotension defined as a ≥20 mm Hg reduction in systolic blood pressure (SBP), a ≥10 mm Hg reduction in diastolic blood pressure (DBP) or the development of significant postural symptoms (dizziness, lightheadedness, vertigo) when going from the supine to standing position.
  • Subjects who are currently prescribed and/or taking nitrates or nitric oxide donors in any form on either a regular or intermittent basis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656798

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: Pfizer
ClinicalTrials.gov Identifier: NCT01656798     History of Changes
Other Study ID Numbers: A1481313
Study First Received: August 1, 2012
Last Updated: September 14, 2012
Health Authority: Singapore: Health Sciences Authority

Additional relevant MeSH terms:
Citric Acid
Sildenafil
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
 Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Cardiovascular Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013