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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Urological Agents

ClinicalTrials.gov processed this record on August 20, 2014