None VolunteerNCT00768573
Taste Test of a New Formulation of Sildenafil (Revatio)
An observational study of None Volunteer, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in United States.
Trial summary
taste of formulation Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- None Volunteer
- What is being tested?
- sildenafil
- Type of treatment
- Pill or oral medicine
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jan 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- Healthy
Who cannot join
- History of hypersensitivity to test compounds or excipients.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
Cambridge, Massachusetts, 02140
About this study
Official title: A Single-Blind Study In Healthy Adult Volunteers To Investigate The Palatability Of Different Oral Suspension Formulations Of Revatio®
taste of formulation
Read the detailed description
taste test None
- Conditions
- None Volunteer
- Being tested
- sildenafil
- Keywords
- taste test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sildenafilDrug
Oral suspension of sildenafil.
| Study group | Role | What they receive |
|---|---|---|
| 1. Taste test | Not described Receives: Drug: sildenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
palatability (aroma, flavour texture and mouth feel)
Measured: Duration of study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for None VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768573
- Sponsor's protocol ID
- A1481257
- Status last verified
- Jan 2021
- First submitted
- 4 Sep 2008
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Blind Study In Healthy Adult Volunteers To Investigate The Palatability Of Different Oral Suspension Formulations Of Revatio®
- ClinicalTrials.gov ID
- NCT00768573
- Acronym / sponsor ID
- A1481257
- Conditions
- None Volunteer
- Keywords
- taste test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 8 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
taste of formulation
Detailed description
taste test None
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1. Taste test | – | Drug: sildenafil |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (1 listed)
- Healthy
Key exclusion criteria (1 listed)
- History of hypersensitivity to test compounds or excipients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sildenafilOral suspension of sildenafil. | Drug | 1. Taste test |
Primary outcome
palatability (aroma, flavour texture and mouth feel)
Time frame: Duration of study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of None Volunteer, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
palatability (aroma, flavour texture and mouth feel) (time frame: Duration of study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.