Erectile DysfunctionPhase 1NCT00866463
A Study to Compare the Blood Levels of Sildenafil Following Administration of an Experimental Tablet vs. the Conventional Oral Tablet in Healthy Subjects
A Phase 1 study testing Sildenafil in people with Erectile Dysfunction, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in United States.
Trial summary
This study to will compare the blood levels of sildenafil following administration of an experimental tablet vs. the conventional oral tablet. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Oct 2008
- Phase
- Phase 1
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males between the ages of 18 and 55 years.
- Body Mass Index of 18 to 30 kg/m2, and a total body weight >50 kg (110 lbs).
Who cannot join
- Smoking in excess of the equivalent of 5 cigarettes per day.
- Treatment with an experimental drug within 30 days or sildenafil, vardenafil, tadalfil within 4 days before first study dose.
- Develop blood pressure lowering or experience dizziness, lightheadedness when going from the laying down position to standing position.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: An Open-Label, Crossover Study In Healthy Volunteers To Evaluate The Pharmacokinetics Of Sildenafil Following Administration Of An Experimental Tablet Of Sildenafil With Or Without Water Relative To Viagra® Conventional Oral Tablet With Water.
This study to will compare the blood levels of sildenafil following administration of an experimental tablet vs. the conventional oral tablet.
- Conditions
- Erectile Dysfunction
- Being tested
- Sildenafil
- Keywords
- Sildenafil, Pharmacokinetics, Healthy Volunteer
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
Single Dose of 50 mg Sildenafil Oral Tablet With Water
SildenafilDrug
Single Dose of 50 mg Sildenafil Experimental Tablet With Water
SildenafilDrug
Single Dose of 50 mg Sildenafil Experimental Tablet Without Water
| Study group | Role | What they receive |
|---|---|---|
| Conventional Oral Tablet With Water | Active comparator | Not described Receives: Drug: Sildenafil |
| Experimental Tablet With Water | Experimental | Not described Receives: Drug: Sildenafil |
| Experimental Tablet Without Water | Experimental | Not described Receives: Drug: Sildenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood levels of sildenafil
Measured: 1 Day
Secondary outcomes (2)
Blood levels of a metabolite of sildenafil
Measured: 1 Day
Side Effects
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2009 (estimated)
- Study startOct 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT00866463
- Sponsor's protocol ID
- A1481265
- Status last verified
- Jan 2021
- First submitted
- 19 Mar 2009
- 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
- An Open-Label, Crossover Study In Healthy Volunteers To Evaluate The Pharmacokinetics Of Sildenafil Following Administration Of An Experimental Tablet Of Sildenafil With Or Without Water Relative To Viagra® Conventional Oral Tablet With Water.
- ClinicalTrials.gov ID
- NCT00866463
- Acronym / sponsor ID
- A1481265
- Conditions
- Erectile Dysfunction
- Keywords
- Sildenafil, Pharmacokinetics, Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 20 Mar 2009 (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.
This study to will compare the blood levels of sildenafil following administration of an experimental tablet vs. the conventional oral tablet.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Oral Tablet With Water | Active comparator | Drug: Sildenafil |
| Experimental Tablet With Water | Experimental | Drug: Sildenafil |
| Experimental Tablet Without Water | Experimental | Drug: Sildenafil |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy males between the ages of 18 and 55 years.
- Body Mass Index of 18 to 30 kg/m2, and a total body weight >50 kg (110 lbs).
Key exclusion criteria (3 listed)
- Smoking in excess of the equivalent of 5 cigarettes per day.
- Treatment with an experimental drug within 30 days or sildenafil, vardenafil, tadalfil within 4 days before first study dose.
- Develop blood pressure lowering or experience dizziness, lightheadedness when going from the laying down position to standing position.
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 |
|---|---|---|
| SildenafilSingle Dose of 50 mg Sildenafil Oral Tablet With Water | Drug | Conventional Oral Tablet With Water |
| SildenafilSingle Dose of 50 mg Sildenafil Experimental Tablet With Water | Drug | Experimental Tablet With Water |
| SildenafilSingle Dose of 50 mg Sildenafil Experimental Tablet Without Water | Drug | Experimental Tablet Without Water |
Primary outcome
Blood levels of sildenafil
Time frame: 1 Day
2 secondary outcomes
Blood levels of a metabolite of sildenafil
Time frame: 1 Day
Side Effects
Time frame: 1 Day
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?
A Phase 1 study testing Sildenafil in people with Erectile Dysfunction, 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 2 inclusion and 3 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Blood levels of sildenafil (time frame: 1 Day). 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.