Healthy VolunteersPhase 1NCT00950404
Bioavailability of 3 Sildenafil Oral Disintegrating Tablet Formulations Compared to the Standard Oral Tablet
A Phase 1 study testing Viagra 50 mg tablet, Formulation B ODT tablet 50 mg and Formulation C ODT tablet 50 mg in people with Healthy Volunteers, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in United States.
Trial summary
The bioavailability of the oral disintegrating tablet formulations given without water will be similar to an equivalent dose of the standard oral tablet given with water. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Viagra 50 mg tablet, Formulation B ODT tablet 50 mg and Formulation C ODT tablet 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Sep 2009
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
- Weight: BMI from 17.5 to 30.5
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- A positive urine drug screen.
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 Three Orally Disintegrating Tablet Formulations Of Sildenafil Without Water Relative To Viagra Conventional Oral Tablet With Water.
The bioavailability of the oral disintegrating tablet formulations given without water will be similar to an equivalent dose of the standard oral tablet given with water.
- Conditions
- Healthy Volunteers
- Being tested
- Viagra 50 mg tablet, Formulation B ODT tablet 50 mg, Formulation C ODT tablet 50 mg, Formulation D ODT tablet 50 mg
- Keywords
- Bioavailability Pharmacokinetic Formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viagra 50 mg tabletDrug
Commercial tablet, 50 mg, single dose administered with water
Formulation B ODT tablet 50 mgDrug
Oral disintegrating tablet (ODT), 50 mg, single dose administered without water
Formulation C ODT tablet 50 mgDrug
ODT, 50 mg, single dose administered without water
Formulation D ODT tablet 50 mgDrug
ODT, 50 mg, single dose, administered without water
| Study group | Role | What they receive |
|---|---|---|
| Viagra 50 mg tablet, administered with water. | Active comparator | Not described Receives: Drug: Viagra 50 mg tablet |
| Formulation B ODT tablet 50 mg, administered without water. | Experimental | Not described Receives: Drug: Formulation B ODT tablet 50 mg |
| Formulation C ODT tablet 50 mg, administered without water. | Experimental | Not described Receives: Drug: Formulation C ODT tablet 50 mg |
| Formulation D ODT tablet 50 mg, administered without water. | Experimental | Not described Receives: Drug: Formulation D ODT tablet 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-T and Cmax of sildenafil
Measured: 1 month
Secondary outcomes (5)
AUC0-Tmax and AUCinf of sildenafil
Measured: 1 month
Tmax and half-life of sildenafil
Measured: 1 month
adverse events
Measured: 3 weeks
vital signs
Measured: 3 weeks
laboratory parameters
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 16 participants (estimated)
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
- NCT00950404
- Sponsor's protocol ID
- A1481273
- Status last verified
- Jan 2021
- First submitted
- 30 Jul 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 Three Orally Disintegrating Tablet Formulations Of Sildenafil Without Water Relative To Viagra Conventional Oral Tablet With Water.
- ClinicalTrials.gov ID
- NCT00950404
- Acronym / sponsor ID
- A1481273
- Conditions
- Healthy Volunteers
- Keywords
- Bioavailability Pharmacokinetic Formulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 31 Jul 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.
The bioavailability of the oral disintegrating tablet formulations given without water will be similar to an equivalent dose of the standard oral tablet given with water.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Viagra 50 mg tablet, administered with water. | Active comparator | Drug: Viagra 50 mg tablet |
| Formulation B ODT tablet 50 mg, administered without water. | Experimental | Drug: Formulation B ODT tablet 50 mg |
| Formulation C ODT tablet 50 mg, administered without water. | Experimental | Drug: Formulation C ODT tablet 50 mg |
| Formulation D ODT tablet 50 mg, administered without water. | Experimental | Drug: Formulation D ODT tablet 50 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy subjects
- Weight: BMI from 17.5 to 30.5
Key exclusion criteria (2 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- A positive urine drug screen.
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 |
|---|---|---|
| Viagra 50 mg tabletCommercial tablet, 50 mg, single dose administered with water | Drug | Viagra 50 mg tablet, administered with water. |
| Formulation B ODT tablet 50 mgOral disintegrating tablet (ODT), 50 mg, single dose administered without water | Drug | Formulation B ODT tablet 50 mg, administered without water. |
| Formulation C ODT tablet 50 mgODT, 50 mg, single dose administered without water | Drug | Formulation C ODT tablet 50 mg, administered without water. |
| Formulation D ODT tablet 50 mgODT, 50 mg, single dose, administered without water | Drug | Formulation D ODT tablet 50 mg, administered without water. |
Primary outcome
AUC0-T and Cmax of sildenafil
Time frame: 1 month
5 secondary outcomes
AUC0-Tmax and AUCinf of sildenafil
Time frame: 1 month
Tmax and half-life of sildenafil
Time frame: 1 month
adverse events
Time frame: 3 weeks
vital signs
Time frame: 3 weeks
laboratory parameters
Time frame: 3 weeks
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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Screening Protocol
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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 Viagra 50 mg tablet, Formulation B ODT tablet 50 mg and Formulation C ODT tablet 50 mg in people with Healthy Volunteers, 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 2 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?
AUC0-T and Cmax of sildenafil (time frame: 1 month). 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.