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A Relative Bioavailability Study of Revatio for the Crushed Tablets, Extemporaneously Prepared Formulation, and the Intact Tablets at 20 mg Dose in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01027117
First received: September 29, 2009
Last updated: August 11, 2010
Last verified: August 2010
History of Changes
  Purpose

This will be a randomized, open-label, 3-treatment, 3-period, crossover, single-dose study in healthy subjects. Eighteen (18) subjects will complete the study; dropouts may be replaced at the discretion of the sponsor. Three treatments are:

Treatment A: Revatio 20 mg intact tablet. Treatment B: Revatio 20 mg crushed tablet mixed with apple sauce. Treatment C: Revatio 20 mg extemporaneously prepared suspension (EP). Blood samples for the analysis of sildenafil in plasma will be obtained pre-dose and up to 14 hours post dose in each period. Tolerability and safety will be assessed by reported adverse events during each study period.


Condition Intervention Phase
Healthy
 Drug: Revatio
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Randomised, Open-Label 3-Way Crossover Study To Investigate The Relative Bioavailability Of The Crushed Revatio 20 Mg Tablet Mixed With Apple Sauce, The Extemporaneously Prepared Suspension (EP), And The Intact Revatio 20 Mg Tablet In Healthy Volunteers Under Fasting Conditions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • AUClast [ Time Frame: Within 14 hours post dose ] [ Designated as safety issue: No ]
  • Cmax [ Time Frame: Within 14 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • T1/2 [ Time Frame: Within 14 hours post dose ] [ Designated as safety issue: No ]
  • AUCinf [ Time Frame: Within 14 hours post dose ] [ Designated as safety issue: No ]
  • Tmax [ Time Frame: Within 14 hours post dose ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: September 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment A
Revatio 20 mg intact tablet. This is the reference treatment arm.
 Drug: Revatio
Three treatments as described in study design, single dose, three way crossover. The treatment duration will be minimum 3 days for each subject.
Experimental: Treatment B
Treatment B: Revatio 20 mg crushed tablet mixed with apple sauce.
 Drug: Revatio
Three treatments as described in study design, single dose, three way crossover. The treatment duration will be minimum 3 days for each subject.
Experimental: Treatment C
Treatment C: Revatio 20 mg extemporaneously prepared suspension (EP).
 Drug: Revatio
Three treatments as described in study design, single dose, three way crossover. The treatment duration will be minimum 3 days for each subject.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male/female subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • An informed consent document signed and dated by the subject or a legally acceptable representative.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, ocular or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
  • History of febrile illness within 5 days prior to the first dose.
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01027117

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
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: NCT01027117     History of Changes
Other Study ID Numbers: A1481275
Study First Received: September 29, 2009
Last Updated: August 11, 2010
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Pfizer:
Bioavailability
Revatio
Healthy Volunteers

Additional relevant MeSH terms:
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 June 18, 2013