HealthyPhase 1NCT01737203
Bioequivalence Study For Orally-Disintegrating Tablet Of Sildenafil
A Phase 1 study testing Viagra and sildenafil ODT in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Japan.
Trial summary
The purpose of this study is to assess the bioequivalence of Sildenafil ODT 50 mg without water to Japanese commercial oral tablet of sildenafil citrate (Viagra® tablet) 50 mg under fasted conditions. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Viagra and sildenafil ODT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2012to Sep 2012
- 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Japanese male subjects between the ages of 20 and 55 years.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Who cannot join
- Baseline orthostatic hypotension defined as a >=20 mm Hg reduction in systolic blood pressure (SBP), a >=10 mm Hg reduction in diastolic blood pressure (DBP) or the development of significant postural symptoms (dizziness, lightheadedness, vertigo) when going from the supine to standing position.
- Subjects who are currently prescribed or taking nitrates or nitric oxide donors in any form on either a regular or intermittent basis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Open-Label, Randomized, Single-Dose, 3-Way Crossover Study Assessing Bioequivalence Of Sildenafil 50 Mg Orally-Disintegrating Tablet With Or Without Water To Viagra® 50 Mg Oral Tablet With Water Under Fasted Condition
The purpose of this study is to assess the bioequivalence of Sildenafil ODT 50 mg without water to Japanese commercial oral tablet of sildenafil citrate (Viagra® tablet) 50 mg under fasted conditions.
- Conditions
- Healthy
- Being tested
- Viagra, sildenafil ODT
- Keywords
- Viagra, ODT, bioquivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViagraDrug
Also called sildenafil citrate
50 mg tablet on Day 1 of each period
sildenafil ODTDrug
50 mg tablet on Day 1 of each period
sildenafil ODTDrug
50 mg tablet on Day 1 of each period
| Study group | Role | What they receive |
|---|---|---|
| Viagra | Active comparator | Oral tablet of sildenafil citrate (Japanese commercial tablet: Viagra® tablet) 50 mg as a single oral dose under fasted conditions Receives: Drug: Viagra |
| ODT without water | Experimental | Sildenafil ODT 50 mg without water as a single oral dose under fasted conditions Receives: Drug: sildenafil ODT |
| ODT with water | Experimental | Sildenafil ODT 50 mg with water as a single oral dose under fasted conditions Receives: Drug: sildenafil ODT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
Measured: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
Maximum Observed Plasma Concentration (Cmax)
Measured: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
Secondary outcomes (11)
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
Measured: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Measured: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
Maximum Observed Plasma Concentration (Cmax)
Measured: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
Plasma Decay Half-Life (t1/2)
Measured: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: 9 days
Diastolic and Systolic Blood Pressure
Measured: 9 days
12-lead electrocardiogram (ECG)
Measured: 9 days
Pulse rate (PR)
Measured: 9 days
Number of Participants With Laboratory Test Values of Potential Clinical Importance
Measured: 9 days
Mean Residence Time(MRT)
Measured: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startAug 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 53 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
- NCT01737203
- Sponsor's protocol ID
- A1481315
- Status last verified
- Jan 2021
- First submitted
- 31 Aug 2012
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-Label, Randomized, Single-Dose, 3-Way Crossover Study Assessing Bioequivalence Of Sildenafil 50 Mg Orally-Disintegrating Tablet With Or Without Water To Viagra® 50 Mg Oral Tablet With Water Under Fasted Condition
- ClinicalTrials.gov ID
- NCT01737203
- Acronym / sponsor ID
- A1481315
- Conditions
- Healthy
- Keywords
- Viagra, ODT, bioquivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 29 Nov 2012 (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 purpose of this study is to assess the bioequivalence of Sildenafil ODT 50 mg without water to Japanese commercial oral tablet of sildenafil citrate (Viagra® tablet) 50 mg under fasted conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Viagra | Active comparator | Drug: ViagraOral tablet of sildenafil citrate (Japanese commercial tablet: Viagra® tablet) 50 mg as a single oral dose under fasted conditions |
| ODT without water | Experimental | Drug: sildenafil ODTSildenafil ODT 50 mg without water as a single oral dose under fasted conditions |
| ODT with water | Experimental | Drug: sildenafil ODTSildenafil ODT 50 mg with water as a single oral dose under fasted conditions |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy Japanese male subjects between the ages of 20 and 55 years.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Key exclusion criteria (2 listed)
- Baseline orthostatic hypotension defined as a >=20 mm Hg reduction in systolic blood pressure (SBP), a >=10 mm Hg reduction in diastolic blood pressure (DBP) or the development of significant postural symptoms (dizziness, lightheadedness, vertigo) when going from the supine to standing position.
- Subjects who are currently prescribed or taking nitrates or nitric oxide donors in any form on either a regular or intermittent basis.
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 |
|---|---|---|
| ViagraAlso: sildenafil citrate50 mg tablet on Day 1 of each period | Drug | Viagra |
| sildenafil ODT50 mg tablet on Day 1 of each period | Drug | ODT without water |
| sildenafil ODT50 mg tablet on Day 1 of each period | Drug | ODT with water |
Primary outcome
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
Time frame: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
11 secondary outcomes
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
Time frame: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
Plasma Decay Half-Life (t1/2)
Time frame: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 9 days
Diastolic and Systolic Blood Pressure
Time frame: 9 days
12-lead electrocardiogram (ECG)
Time frame: 9 days
Pulse rate (PR)
Time frame: 9 days
Number of Participants With Laboratory Test Values of Potential Clinical Importance
Time frame: 9 days
Mean Residence Time(MRT)
Time frame: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
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 28 Jan 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 Viagra and sildenafil ODT in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Japan.
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 28 Jan 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 Japan. 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?
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] (time frame: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose). 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?
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 28 Jan 2021.