Erectile DysfunctionPhase 1A1481272NCT00904748

A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate

A Phase 1 study testing sildenafil citrate 100 mg CT and Viagra® in people with Erectile Dysfunction, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to perform a relative bioavailability study between two formulations of sildenafil citrate. Read more about this study

Who is it for?: Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Erectile Dysfunction
What is being tested?: sildenafil citrate 100 mg CT and Viagra®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: 1 siteBrazil
Study dates: Jan 2010to Mar 2010
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Body mass index higher or equal to 18,5 and lower or equal than 29,9 kg/m2.
Good health conditions or without significant disease, at medical discretion, according to the rules defined in the Protocol, and evaluations undergone: clinical history, pulse and blood pressure measurements, physical and psychological examination, ECG and complementary laboratory examination.
Able to understand the study nature and objective, including the risks and adverse effects and willing to cooperate with the investigator and act according to all the trial requirements, which is confirmed by signing the Informed Consent Form.

Who cannot join

Hypersensitivity to the study drug or to the chemically related compounds; history of serious adverse reactions or hypersensitivity to any drug.
History or presence of hepatic or gastrointestinal diseases, or other condition that affects the drug absorption, distribution, excretion or metabolism
History of hepatic, renal, lung, gastrointestinal, epileptic, hematological or psychiatric disease; hypo or hypertension of whatever etiology which demands treatment with drugs; history or occurrence of myocardial infarction, angina and/or cardiac failure;

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Pfizer Investigational Site
Bragança Paulista, São Paulo, 12916-900

Other trials in Brazil

About this study

Official title: A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate In Healthy Male Subjects, Fasting Dosing, Being The Test Formulation Sildenafil Citrate 100 Mg CT , And The Reference Formulation Sildenafil Citrate 100 Mg Film-Coated Tablets (Viagra®), Both Formulations Manufactured By Laboratórios Pfizer Ltda.

The purpose of this study is to perform a relative bioavailability study between two formulations of sildenafil citrate.

Read the detailed description

Bio-equivalence between two formulations of sildenafil citrate

Conditions: Erectile Dysfunction
Being tested: sildenafil citrate 100 mg CT, Viagra®
Keywords: Sildenafil, Bio-equivalence
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 citrate 100 mg CTDrug
sildenafil citrate 100 mg CT, single dose without water
sildenafil citrate 100 mg CTDrug
sildenafil citrate 100 mg CT, single dose with water
Viagra®Drug
sildenafil citrate 100 mg film-coated tablet (Viagra®), single dose

Study groups in NCT00904748
Study group	Role	What they receive
Test 1	Experimental	Not described Receives: Drug: sildenafil citrate 100 mg CT
Test 2	Experimental	Not described Receives: Drug: sildenafil citrate 100 mg CT
Reference	Active comparator	Not described Receives: Drug: Viagra®

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Curve (AUC 0-t)
Area under the blood concentration-time profile from time zero to last experimentally determined concentration measured in nanograms*hour/milliliter (ng*hr/mL).
Measured: Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose
Maximum Plasma Concentration (Cmax)
Maximum plasma concentration measured in nanograms per milliliter (ng/mL).
Measured: Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose

Secondary outcomes (4)

Area Under the Curve From 0 to Infinity (AUC 0-inf )
Area under the blood concentration-time profile from time zero extrapolated to infinite time measured in nanograms *hour/milliliter (ng*hr/mL).
Measured: Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose
Time to Maximum Plasma Concentration (Tmax)
Time at which maximum plasma concentration (Cmax) occurred.
Measured: Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose
Half-life (T 1/2)
Terminal elimination half-life.
Measured: Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose
Number of Participants With Clinically Significant Findings in Vital Signs
Clinically significant abnormalities in blood pressure (BP), pulse, and temperature reported as an adverse event. Clinically significant = values outside the normal range and/or values judged as significant by the investigator (normal range: systolic BP 100-140 mmHg; diastolic BP 60- 90 mmHg; temperature 35-37°Celsius). Pulse rate based on investigator discretion.
Measured: Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.5, 1, 2, 4, 8 and 12 hours post-dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Mar 2010

First posted20 May 2009 (estimated)
Study startJan 2010
Primary completionMar 2010
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00904748
Sponsor's protocol ID: A1481272
Other IDs: JPJ 39/09
Acronym: A1481272
Status last verified: Jan 2021
First submitted: 19 May 2009
Last updated: 1 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Erectile Dysfunction trials

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: A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate In Healthy Male Subjects, Fasting Dosing, Being The Test Formulation Sildenafil Citrate 100 Mg CT , And The Reference Formulation Sildenafil Citrate 100 Mg Film-Coated Tablets (Viagra®), Both Formulations Manufactured By Laboratórios Pfizer Ltda.
ClinicalTrials.gov ID: NCT00904748
Acronym / sponsor ID: A1481272 / A1481272
Conditions: Erectile Dysfunction
Keywords: Sildenafil, Bio-equivalence
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 20 May 2009 (estimated)
Results: Posted 4 Apr 2011

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 perform a relative bioavailability study between two formulations of sildenafil citrate.

Detailed description

Bio-equivalence between two formulations of sildenafil citrate

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Test 1	Experimental	Drug: sildenafil citrate 100 mg CT
Test 2	Experimental	Drug: sildenafil citrate 100 mg CT
Reference	Active comparator	Drug: Viagra®

Who may qualify

Ages: 18 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Body mass index higher or equal to 18,5 and lower or equal than 29,9 kg/m2.
Good health conditions or without significant disease, at medical discretion, according to the rules defined in the Protocol, and evaluations undergone: clinical history, pulse and blood pressure measurements, physical and psychological examination, ECG and complementary laboratory examination.
Able to understand the study nature and objective, including the risks and adverse effects and willing to cooperate with the investigator and act according to all the trial requirements, which is confirmed by signing the Informed Consent Form.

Key exclusion criteria (3 listed)

Hypersensitivity to the study drug or to the chemically related compounds; history of serious adverse reactions or hypersensitivity to any drug.
History or presence of hepatic or gastrointestinal diseases, or other condition that affects the drug absorption, distribution, excretion or metabolism
History of hepatic, renal, lung, gastrointestinal, epileptic, hematological or psychiatric disease; hypo or hypertension of whatever etiology which demands treatment with drugs; history or occurrence of myocardial infarction, angina and/or cardiac failure;

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 citrate 100 mg CTsildenafil citrate 100 mg CT, single dose without water	Drug	Test 1
sildenafil citrate 100 mg CTsildenafil citrate 100 mg CT, single dose with water	Drug	Test 2
Viagra®sildenafil citrate 100 mg film-coated tablet (Viagra®), single dose	Drug	Reference

Primary outcome

Area Under the Curve (AUC 0-t)
Time frame: Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose
Area under the blood concentration-time profile from time zero to last experimentally determined concentration measured in nanograms*hour/milliliter (ng*hr/mL).
Maximum Plasma Concentration (Cmax)
Time frame: Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose
Maximum plasma concentration measured in nanograms per milliliter (ng/mL).

4 secondary outcomes

Area Under the Curve From 0 to Infinity (AUC 0-inf )
Time frame: Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose
Time to Maximum Plasma Concentration (Tmax)
Time frame: Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose
Half-life (T 1/2)
Time frame: Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose
Number of Participants With Clinically Significant Findings in Vital Signs
Time frame: Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.5, 1, 2, 4, 8 and 12 hours post-dose.

Results and safety

Results posted to the registry on 4 Apr 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1	8	7
Sequence 2	8	7
Sequence 3	8	7
Sequence 4	8	6
Sequence 5	8	7
Sequence 6	8	8

Primary outcome: Area Under the Curve (AUC 0-t)

Time frame: Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Test 1: 100 mg Chewable, Without Water n = 42	Test 2: 100 mg Chewable, With Water n = 42	Reference: 100 mg Coated, With Water n = 42
Value	1467.00 (560.99)	1458.45 (602.73)	1493.53 (615.59)

Test 1: 100 mg Chewable, Without Water vs Reference: 100 mg Coated, With Water: ratio between geometric means: 98.68 (90% CI 92.03 to 105.82), ANOVA
Test 2: 100 mg Chewable, With Water vs Reference: 100 mg Coated, With Water: ratio between geometric means: 97.23 (90% CI 90.67 to 104.26), ANOVA

Population analysed: Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.

Primary outcome: Maximum Plasma Concentration (Cmax)

Measure	Test 1: 100 mg Chewable, Without Water n = 42	Test 2: 100 mg Chewable, With Water n = 42	Reference: 100 mg Coated, With Water n = 42
Value	439.38 (198.25)	434.38 (211.53)	532.31 (217.32)

Test 1: 100 mg Chewable, Without Water vs Reference: 100 mg Coated, With Water: ratio between geometric means: 80.83 (90% CI 72.38 to 90.26), ANOVA
Test 2: 100 mg Chewable, With Water vs Reference: 100 mg Coated, With Water: ratio between geometric means: 78.76 (90% CI 70.53 to 87.96), ANOVA

Population analysed: Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test 1: 100 mg Chewable, Without Water	0 of 47 (0%)	3 of 47 (6.4%)	Not reported
Test 2: 100 mg Chewable, With Water	0 of 47 (0%)	3 of 47 (6.4%)	Not reported
Reference: 100 mg Coated, With Water	0 of 47 (0%)	3 of 47 (6.4%)	Not reported
Formulation Unspecified	0 of 47 (0%)	18 of 47 (38.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 citrate 100 mg CT and Viagra® in people with Erectile Dysfunction, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Brazil.

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 Brazil. 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?

Yes. Results are posted in the registry (first posted 4 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (AUC 0-t) (time frame: Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours 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?

On the ClinicalTrials.gov record for NCT00904748.

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; AzTrials last refreshed its copy on 26 Oct 2026.