Healthy MalesPhase 4NCT00902512
Study Of Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations
A Phase 4 study testing Treatment A, Blood samples for the analysis of sildenafil in plasma and Treatment B in people with Healthy Males, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Mexico.
Trial summary
the pharmacokinetics of sildenafil following single doses of sildenafil CT administered with and without water is similar relative to the conventional oral tablet of sildenafil administered with water. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Males
- What is being tested?
- Treatment A, Blood samples for the analysis of sildenafil in plasma and Treatment B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- Apr 2009to Apr 2009
- Phase
- Phase 4
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Only healthy male volunteers in the 18-40 age range will be included.
- At the selection visit allowed normal range for vital signs will be: Blood pressure (with the subject sitting down) 90-130mm Hg systolic and 60-90
- The volunteers' health condition will be determined from their complete clinical history by doctors at the clinical research site and lab test results by certified clinical laboratories mm Hg diastolic, heart rate 55-100 bpm , respiratory rate 14-20 respirations per minute.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
- Treatment with a PDE-5 inhibitor within the 4 days preceding the first dose of study medication
- History of hypersensitivity to sildenafil citrate or any components of its formulations
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Pfizer Investigational Site
Col. Arenal Tepepan, Mexico City, 14610
About this study
Official title: Relative Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations In Healthy Volunteers Under Fasting Conditions.
the pharmacokinetics of sildenafil following single doses of sildenafil CT administered with and without water is similar relative to the conventional oral tablet of sildenafil administered with water.
- Conditions
- Healthy Males
- Being tested
- Treatment A, Blood samples for the analysis of sildenafil in plasma, Treatment B, Treatment C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment ADrug
Viagra® 100 mg tablet, administered with water single dose
Blood samples for the analysis of sildenafil in plasmaDrug
Blood samples for the analysis of sildenafil in plasma
Treatment BDrug
Sildenafil 100 mg CT administered with water single dose
Blood samples for the analysis of sildenafil in plasmaOther
Blood samples for the analysis of sildenafil in plasma
Treatment CDrug
Sildenafil 100 mg CT administered without water single dose
Blood samples for the analysis of sildenafil in plasmaOther
Blood samples for the analysis of sildenafil in plasma
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Active comparator | Viagra® 100 mg tablet, administered with water Receives: Drug: Treatment A; Drug: Blood samples for the analysis of sildenafil in plasma |
| Treatment B | Active comparator | Sildenafil 100 mg CT administered with water Receives: Drug: Treatment B; Other: Blood samples for the analysis of sildenafil in plasma |
| Treatment C | Active comparator | Sildenafil 100 mg CT administered without water Receives: Drug: Treatment C; Other: Blood samples for the analysis of sildenafil in plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-T and Cmax of sildenafil
Measured: 28 days
Secondary outcomes (3)
AUC0-inf of sildenafil
Measured: 28 days
Tmax and half-life of sildenafil
Measured: 28 days
Adverse events and vital signs
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy MalesStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902512
- Sponsor's protocol ID
- A1481267
- Status last verified
- Jan 2021
- First submitted
- 13 May 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
- Relative Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations In Healthy Volunteers Under Fasting Conditions.
- ClinicalTrials.gov ID
- NCT00902512
- Acronym / sponsor ID
- A1481267
- Conditions
- Healthy Males
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Collaborators
- Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.
- Study start
- Apr 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 15 May 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 pharmacokinetics of sildenafil following single doses of sildenafil CT administered with and without water is similar relative to the conventional oral tablet of sildenafil administered with water.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Active comparator | Drug: Treatment A, Drug: Blood samples for the analysis of sildenafil in plasmaViagra® 100 mg tablet, administered with water |
| Treatment B | Active comparator | Drug: Treatment B, Other: Blood samples for the analysis of sildenafil in plasmaSildenafil 100 mg CT administered with water |
| Treatment C | Active comparator | Drug: Treatment C, Other: Blood samples for the analysis of sildenafil in plasmaSildenafil 100 mg CT administered without water |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Only healthy male volunteers in the 18-40 age range will be included.
- At the selection visit allowed normal range for vital signs will be: Blood pressure (with the subject sitting down) 90-130mm Hg systolic and 60-90
- The volunteers' health condition will be determined from their complete clinical history by doctors at the clinical research site and lab test results by certified clinical laboratories mm Hg diastolic, heart rate 55-100 bpm , respiratory rate 14-20 respirations per minute.
Key exclusion criteria (3 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
- Treatment with a PDE-5 inhibitor within the 4 days preceding the first dose of study medication
- History of hypersensitivity to sildenafil citrate or any components of its formulations
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 |
|---|---|---|
| Treatment AViagra® 100 mg tablet, administered with water single dose | Drug | Treatment A |
| Blood samples for the analysis of sildenafil in plasmaBlood samples for the analysis of sildenafil in plasma | Drug | Treatment A |
| Treatment BSildenafil 100 mg CT administered with water single dose | Drug | Treatment B |
| Blood samples for the analysis of sildenafil in plasmaBlood samples for the analysis of sildenafil in plasma | Other | Treatment B |
| Treatment CSildenafil 100 mg CT administered without water single dose | Drug | Treatment C |
| Blood samples for the analysis of sildenafil in plasmaBlood samples for the analysis of sildenafil in plasma | Other | Treatment C |
Primary outcome
AUC0-T and Cmax of sildenafil
Time frame: 28 days
3 secondary outcomes
AUC0-inf of sildenafil
Time frame: 28 days
Tmax and half-life of sildenafil
Time frame: 28 days
Adverse events and vital signs
Time frame: 28 days
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 4 study testing Treatment A, Blood samples for the analysis of sildenafil in plasma and Treatment B in people with Healthy Males, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Mexico.
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 Mexico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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: 28 days). 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.