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| ID | Type | Description | Link |
|---|---|---|---|
| JPJ 39/09 |
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The purpose of this study is to perform a relative bioavailability study between two formulations of sildenafil citrate.
Bio-equivalence between two formulations of sildenafil citrate
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test 1 | Experimental |
| |
| Test 2 | Experimental |
| |
| Reference | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sildenafil citrate 100 mg CT | Drug | sildenafil citrate 100 mg CT, single dose without water |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Bragança Paulista | São Paulo | 12916-900 | Brazil |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Each participant was to receive each of 3 formulations in 3 treatment periods, after being allocated to 1 of 6 treatment sequences. There was to be a minimum interval of 3 days between treatment periods.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Reference (Sildenafil 100 milligram (mg) coated tablet administered with water, Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water), Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water) |
| FG001 | Sequence 2 | Reference (Sildenafil 100 milligram (mg) coated tablet administered with water, Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water), Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water) |
| FG002 | Sequence 3 | Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water), Reference (Sildenafil 100 milligram (mg) coated tablet administered with water, Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water) |
| FG003 | Sequence 4 | Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water), Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water), Reference (Sildenafil 100 milligram (mg) coated tablet administered with water |
| FG004 | Sequence 5 | Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water), Reference (Sildenafil 100 milligram (mg) coated tablet administered with water, Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water) |
| FG005 | Sequence 6 | Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water), Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water), Reference (Sildenafil 100 milligram (mg) coated tablet administered with water |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes all participants who were randomized to any treatment sequence |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods. | Posted | Mean | Standard Deviation | ng*hr/mL | 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 |
|
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Safety population: subjects who received at least 1 dose of study medication in any treatment period. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject or subject may have had a serious and non-serious episode of same event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test 1: 100 mg Chewable, Without Water | Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Verbatim term | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| sildenafil citrate 100 mg CT |
| Drug |
sildenafil citrate 100 mg CT, single dose with water |
|
| Viagra® | Drug | sildenafil citrate 100 mg film-coated tablet (Viagra®), single dose |
|
| Time to Maximum Plasma Concentration (Tmax) | Time at which maximum plasma concentration (Cmax) occurred. | 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. | 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. | 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. |
| Adverse Event |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water |
| OG002 | Reference: 100 mg Coated, With Water | Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water |
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) | Maximum plasma concentration measured in nanograms per milliliter (ng/mL). | Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods. | Posted | Mean | Standard Deviation | ng/mL | 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 | 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). | Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods. | Posted | Mean | Standard Deviation | ng*hr/mL | 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 | Time to Maximum Plasma Concentration (Tmax) | Time at which maximum plasma concentration (Cmax) occurred. | Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods. | Posted | Mean | Standard Deviation | hours | 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 | Half-life (T 1/2) | Terminal elimination half-life. | Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods. | Posted | Mean | Standard Deviation | hours | 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 | 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. | Safety population: all subjects who received at least 1 dose of study medication. Although individual listing data for vital signs were collected, summary statistics were not generated for this outcome measure. | Posted | Number | participants | 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. |
|
|
|
| 0 |
| 47 |
| 3 |
| 47 |
| EG001 | Test 2: 100 mg Chewable, With Water | Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water | 0 | 47 | 3 | 47 |
| EG002 | Reference: 100 mg Coated, With Water | Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water | 0 | 47 | 3 | 47 |
| EG003 | Formulation Unspecified | Sildenafil 100 mg tablet: formulation unspecified | 0 | 47 | 18 | 47 |
| Nausea | General disorders | Verbatim term | Systematic Assessment |
|
| Loose stools | General disorders | Verbatim term | Systematic Assessment |
|
| Hypotension | General disorders | Verbatim term | Systematic Assessment |
|
| Vomiting | General disorders | Verbatim term | Systematic Assessment |
|
| Laboratory change: urine | General disorders | Verbatim term | Systematic Assessment |
|
| Laboratory change: red blood cell count | General disorders | Verbatim term | Systematic Assessment |
|
| Laboratory change: triglycerides | General disorders | Verbatim term | Systematic Assessment |
|
| Laboratory change: glucose | General disorders | Verbatim term | Systematic Assessment |
|
| Laboratory change: cholesterol | General disorders | Verbatim term | Systematic Assessment |
|
| Laboratory change: white blood cells | General disorders | Verbatim term | Systematic Assessment |
|
| Laboratory changes unspecified | General disorders | Verbatim term | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
|
Ratio between geometric means of Test 2 study treatment (chewable with water) and reference study treatment (coated with water). |
| ANOVA |
| ratio between geometric means |
| 78.76 |
| 2-Sided |
| 90 |
| 70.53 |
| 87.96 |
Estimated value = ratio (% reference). |
| Non-Inferiority or Equivalence (legacy) |
Percent of reference to detect for 2-1 tests and power = 20%. |
|
Ratio between geometric means of Test 2 study treatment (chewable with water) and reference study treatment (coated with water). |
| ANOVA |
| ratio between geometric means |
| 97.84 |
| 2-Sided |
| 90 |
| 91.56 |
| 104.56 |
Estimated value = ratio (% reference). |
| Non-Inferiority or Equivalence (legacy) |
Percent of reference to detect for 2-1 tests and power = 20.0%. |
| ANOVA |
| Mean Difference (Final Values) |
| 0.01 |
| 2-Sided |
| 90 |
| -0.27 |
| 0.28 |
| Superiority or Other (legacy) |