CompletedNCT00904748A1481272Updated Feb 1, 2021Results posted

A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate

A Phase 1 interventional study of sildenafil citrate 100 mg CT and sildenafil citrate 100 mg CT in Erectile Dysfunction, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 1 site in Brazil. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-01.

Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 1, Interventional, and Other

Phase: Phase 1
Study type: Interventional
Enrollment: 47
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: Male

Study summary

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 studied

Erectile Dysfunction

Browse trials for

Erectile Dysfunction 683

Keywords

Sildenafil
Bio-equivalence

In context

Erectile Dysfunction

683 studies on the registry are indexed under Erectile Dysfunction; 117 are open to participants now.

This study's enrollment of 47 is below the median of 72 across 542 interventional studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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;

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 47 participants (actual)

Study arms

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

Interventions

Drugsildenafil citrate 100 mg CT
sildenafil citrate 100 mg CT, single dose without water
Drugsildenafil citrate 100 mg CT
sildenafil citrate 100 mg CT, single dose with water
DrugViagra®
sildenafil citrate 100 mg film-coated tablet (Viagra®), single dose

What researchers measure

Primary outcomes

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).
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 (Cmax)
Maximum plasma concentration measured in nanograms per milliliter (ng/mL).
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

Secondary outcomes

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).
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 at which maximum plasma concentration (Cmax) occurred.
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)
Terminal elimination half-life.
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
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.
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

Posted Apr 4, 2011

Participant flow

Participant flow — Overall Study
Milestone	Sequence 1	Sequence 2	Sequence 3	Sequence 4	Sequence 5	Sequence 6
Started	8	8	8	8	8	8
Received treatment	8	8	8	8	7	8
Completed	7	7	7	6	7	8
Not completed	1	1	1	2	1	0
Withdrew: Withdrawal by subject	1	1	1	2	0	0
Withdrew: Adverse event	0	0	0	0	1	0

Outcome measures

PrimaryArea 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).

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
Reported as:: Mean · ng*hr/mL

Area Under the Curve (AUC 0-t)
ng*hr/mL	Test 1: 100 mg Chewable, Without Water	Test 2: 100 mg Chewable, With Water	Reference: 100 mg Coated, With Water
Area Under the Curve (AUC 0-t)	1467.00 ± 560.99	1458.45 ± 602.73	1493.53 ± 615.59

Statistical analysis

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

PrimaryMaximum Plasma Concentration (Cmax)

Maximum plasma concentration measured in nanograms per milliliter (ng/mL).

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
Reported as:: Mean · ng/mL

Maximum Plasma Concentration (Cmax)
ng/mL	Test 1: 100 mg Chewable, Without Water	Test 2: 100 mg Chewable, With Water	Reference: 100 mg Coated, With Water
Maximum Plasma Concentration (Cmax)	439.38 ± 198.25	434.38 ± 211.53	532.31 ± 217.32

Statistical analysis

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

SecondaryArea 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).

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
Reported as:: Mean · ng*hr/mL

Area Under the Curve From 0 to Infinity (AUC 0-inf )
ng*hr/mL	Test 1: 100 mg Chewable, Without Water	Test 2: 100 mg Chewable, With Water	Reference: 100 mg Coated, With Water
Area Under the Curve From 0 to Infinity (AUC 0-inf )	1547.92 ± 588.48	1534.66 ± 618.86	1573.81 ± 648.32

Statistical analysis

Test 1: 100 mg Chewable, Without Water vs Reference: 100 mg Coated, With Water · ANOVA · Ratio between geometric means: 99.12 · 90% CI 92.76 to 105.93Estimated value = ratio (% reference).
Test 2: 100 mg Chewable, With Water vs Reference: 100 mg Coated, With Water · ANOVA · Ratio between geometric means: 97.84 · 90% CI 91.56 to 104.56Estimated value = ratio (% reference).

SecondaryTime to Maximum Plasma Concentration (Tmax)

Time at which maximum plasma concentration (Cmax) occurred.

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
Reported as:: Mean · hours

Time to Maximum Plasma Concentration (Tmax)
hours	Test 1: 100 mg Chewable, Without Water	Test 2: 100 mg Chewable, With Water	Reference: 100 mg Coated, With Water
Time to Maximum Plasma Concentration (Tmax)	1.46 ± 0.81	1.29 ± 0.71	1.28 ± 0.85

Statistical analysis

Test 1: 100 mg Chewable, Without Water vs Reference: 100 mg Coated, With Water · ANOVA · Mean difference (final values): 0.18 · 90% CI -0.14 to 0.50
Test 2: 100 mg Chewable, With Water vs Reference: 100 mg Coated, With Water · ANOVA · Mean difference (final values): 0.01 · 90% CI -0.27 to 0.28

SecondaryHalf-life (T 1/2)

Terminal elimination half-life.

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
Reported as:: Mean · hours

Half-life (T 1/2)
hours	Test 1: 100 mg Chewable, Without Water	Test 2: 100 mg Chewable, With Water	Reference: 100 mg Coated, With Water
Half-life (T 1/2)	2.96 ± 0.63	2.84 ± 0.74	2.93 ± 0.81

SecondaryNumber 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.

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.
Reported as:: Number · participants

Number of Participants With Clinically Significant Findings in Vital Signs
participants	Test 1: 100 mg Chewable, Without Water	Test 2: 100 mg Chewable, With Water	Reference: 100 mg Coated, With Water
Number of Participants With Clinically Significant Findings in Vital Signs	0	1	0

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Test 1: 100 mg Chewable, Without Water	—	0/47 (0%)	3/47 (6.4%)
Test 2: 100 mg Chewable, With Water	—	0/47 (0%)	3/47 (6.4%)
Reference: 100 mg Coated, With Water	—	0/47 (0%)	3/47 (6.4%)
Formulation Unspecified	—	0/47 (0%)	18/47 (38.3%)

Most frequent other events

Showing 10 of 12

Most frequent other events
Event	Test 1: 100 mg Chewable, Without Water	Test 2: 100 mg Chewable, With Water	Reference: 100 mg Coated, With Water	Formulation Unspecified
Laboratory change: urineGeneral disorders	0/47	0/47	0/47	8/47
Laboratory change: red blood cell countGeneral disorders	0/47	0/47	0/47	4/47
HeadacheGeneral disorders	3/47	2/47	2/47	0/47
Laboratory change: glucoseGeneral disorders	0/47	0/47	0/47	3/47
Laboratory change: triglyceridesGeneral disorders	0/47	0/47	0/47	2/47
Laboratory change: cholesterolGeneral disorders	0/47	0/47	0/47	2/47
Laboratory changes unspecifiedGeneral disorders	0/47	0/47	0/47	2/47
NauseaGeneral disorders	1/47	0/47	1/47	0/47
Loose stoolsGeneral disorders	1/47	0/47	0/47	0/47
HypotensionGeneral disorders	0/47	1/47	0/47	0/47

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Entire Study Population
Mean	29.3 (18 to 45)

Sex: Female, Male
Sex: Female, Male(Participants)	Entire Study Population
Female	0
Male	48

Study locations

1 site

Pfizer Investigational Site
Braganca Paulista, SP 12916-900, Brazil

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00904748
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Responsible party: Sponsor
First posted: May 20, 2009
Start date: Jan 2010
Primary completion: Mar 2010
Completion: Mar 2010
Results posted: Apr 4, 2011
Last update: Feb 1, 2021

Study contacts

Pfizer CT.gov Call Center

study director · Pfizer

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate

Study summary

Conditions studied

Browse trials for

Keywords

In context

Erectile Dysfunction

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Related links

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria