Erectile DysfunctionPhase 1NCT01254383
Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Versus To Viagra® Oral Tablet.
A Phase 1 study testing Sildenafil Tablet and Sildenafil ODT in people with Erectile Dysfunction, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Singapore.
Trial summary
This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties as the conventional tablet of sildenafil. Read more about this study
- Who is it for?
- Ages 45 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Sildenafil Tablet and Sildenafil ODT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSingapore
- Study dates
- Dec 2010to Mar 2011
- 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 45 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Otherwise healthy male subjects age 45 years or older with or without erectile dysfunction.
- Body Mass Index (BMI) of 17.5 to 32.5 kg/m2.
- Signed and dated informed consent document.
Who cannot join
- Evidence or history of clinically significant abnormalities
- Have baseline orthostatic hypotension
- Positive drug screen, excessive alcohol and tobacco use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Crossover Study In Healthy Older Male Subjects To Evaluate The Pharmacokinetics And Safety Of Sildenafil Following Fasted Administration Of An Orally Disintegrating Tablet Formulation Of Sildenafil Administered With Or Without Water Relative To Viagra® Oral Tablet With Water
This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties as the conventional tablet of sildenafil.
- Conditions
- Erectile Dysfunction
- Being tested
- Sildenafil Tablet, Sildenafil ODT
- Keywords
- Bioequivalence Oral Dissolving Tablet
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil TabletDrug
Tablet, 50 mg, Single Dose
Sildenafil ODTDrug
Orally Disintegrating Tablet, 50 mg, Single Dose
Sildenafil ODTDrug
Orally Disintegrating Tablet, 50 mg, Single Dose
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Active comparator | Viagra 50 mg tablet, administered with approximately 240 mL water under fasted conditions Receives: Drug: Sildenafil Tablet |
| Treatment B | Experimental | Sildenafil ODT tablet 50 mg, administered without water under fasted conditions Receives: Drug: Sildenafil ODT |
| Treatment C | Experimental | Sildenafil ODT tablet 50 mg, administered with water under fasted conditions. Receives: Drug: Sildenafil ODT |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-t) of sildenafil.
Measured: Up to 1 month
Cmax of sildenafil.
Measured: Up to 1 month
Secondary outcomes (4)
AUC(0-inf) of sildenafil, if data permits.
Measured: Up to 1 month
Half-life of sildenafil, if data permits.
Measured: Up to 1 month
Tmax of sildenafil.
Measured: Up to 1 month
Number of patients with adverse events.
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 36 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
- NCT01254383
- Sponsor's protocol ID
- A1481289
- Status last verified
- Jan 2021
- First submitted
- 19 Nov 2010
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Damle B, Duczynski G, Jeffers BW, Crownover P, Coupe A, LaBadie RR. Pharmacokinetics of a novel orodispersible tablet of sildenafil in healthy subjects. Clin Ther. 2014 Feb 1;36(2):236-44. doi: 10.1016/j.clinthera.2013.12.010. Epub 2014 Jan 18.
PubMed 24447534
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 Older Male Subjects To Evaluate The Pharmacokinetics And Safety Of Sildenafil Following Fasted Administration Of An Orally Disintegrating Tablet Formulation Of Sildenafil Administered With Or Without Water Relative To Viagra® Oral Tablet With Water
- ClinicalTrials.gov ID
- NCT01254383
- Acronym / sponsor ID
- A1481289
- Conditions
- Erectile Dysfunction
- Keywords
- Bioequivalence Oral Dissolving Tablet
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 6 Dec 2010 (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 will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties as the conventional tablet of sildenafil.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Active comparator | Drug: Sildenafil TabletViagra 50 mg tablet, administered with approximately 240 mL water under fasted conditions |
| Treatment B | Experimental | Drug: Sildenafil ODTSildenafil ODT tablet 50 mg, administered without water under fasted conditions |
| Treatment C | Experimental | Drug: Sildenafil ODTSildenafil ODT tablet 50 mg, administered with water under fasted conditions. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Otherwise healthy male subjects age 45 years or older with or without erectile dysfunction.
- Body Mass Index (BMI) of 17.5 to 32.5 kg/m2.
- Signed and dated informed consent document.
Key exclusion criteria (3 listed)
- Evidence or history of clinically significant abnormalities
- Have baseline orthostatic hypotension
- Positive drug screen, excessive alcohol and tobacco use
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 |
|---|---|---|
| Sildenafil TabletTablet, 50 mg, Single Dose | Drug | Treatment A |
| Sildenafil ODTOrally Disintegrating Tablet, 50 mg, Single Dose | Drug | Treatment B |
| Sildenafil ODTOrally Disintegrating Tablet, 50 mg, Single Dose | Drug | Treatment C |
Primary outcome
AUC(0-t) of sildenafil.
Time frame: Up to 1 month
Cmax of sildenafil.
Time frame: Up to 1 month
4 secondary outcomes
AUC(0-inf) of sildenafil, if data permits.
Time frame: Up to 1 month
Half-life of sildenafil, if data permits.
Time frame: Up to 1 month
Tmax of sildenafil.
Time frame: Up to 1 month
Number of patients with adverse events.
Time frame: Up to 1 month
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.
- Derived from this study: PubMed 24447534Damle B, Duczynski G, Jeffers BW, Crownover P, Coupe A, LaBadie RR. Pharmacokinetics of a novel orodispersible tablet of sildenafil in healthy subjects. Clin Ther. 2014 Feb 1;36(2):236-44. doi: 10.1016/j.clinthera.2013.12.010. Epub 2014 Jan 18.
- 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 Tablet and Sildenafil ODT in people with Erectile Dysfunction, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Singapore.
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 3 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 Singapore. 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?
AUC(0-t) of sildenafil. (time frame: Up to 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01254383, which also lists 1 linked publication.
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.