Taste Test of a New Formulation of Sildenafil (Revatio)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00768573
First received: September 4, 2008
Last updated: May 30, 2011
Last verified: May 2011
  Purpose

taste of formulation


Condition Intervention Phase
None Volunteer
Drug: sildenafil
Phase 1

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Single-Blind Study In Healthy Adult Volunteers To Investigate The Palatability Of Different Oral Suspension Formulations Of Revatio®

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • palatability (aroma, flavour texture and mouth feel) [ Time Frame: Duration of study. ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: January 2008
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Not Specified
Not Specified
Drug: sildenafil
Oral suspension of sildenafil.

Detailed Description:

taste test None

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy volunteers

Criteria

Inclusion Criteria:

  • Healthy

Exclusion Criteria:

  • History of hypersensitivity to test compounds or excipients.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00768573

Locations
United States, Massachusetts
Pfizer Investigational Site
Cambridge, Massachusetts, United States, 02140
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00768573     History of Changes
Other Study ID Numbers: A1481257
Study First Received: September 4, 2008
Last Updated: May 30, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
taste test

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 April 17, 2014