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A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate (A1481272)

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ClinicalTrials.gov Identifier: NCT00904748
Recruitment Status : Completed
First Posted : May 20, 2009
Results First Posted : April 4, 2011
Last Update Posted : May 20, 2011
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition Erectile Dysfunction
Interventions Drug: sildenafil citrate 100 mg CT
Drug: Viagra®
Enrollment 47
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Sequence 1 Sequence 2 Sequence 3 Sequence 4 Sequence 5 Sequence 6
Hide Arm/Group Description 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) 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) 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) 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 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) 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
Period Title: Overall Study
Started 8 8 8 8 8 [1] 8
Received Treatment 8 8 8 8 7 8
Completed 7 7 7 6 7 8
Not Completed 1 1 1 2 1 0
Reason Not Completed
Withdrawal by Subject             1             1             1             2             0             0
Adverse Event             0             0             0             0             1             0
[1]
1 participant randomized to this sequence discontinued prior to receipt of study medication.
Arm/Group Title Entire Study Population
Hide Arm/Group Description Includes all participants who were randomized to any treatment sequence
Overall Number of Baseline Participants 48
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 48 participants
29.3
(18 to 45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Female
0
   0.0%
Male
48
 100.0%
1.Primary Outcome
Title Area Under the Curve (AUC 0-t)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.
Arm/Group Title Test 1: 100 mg Chewable, Without Water Test 2: 100 mg Chewable, With Water Reference: 100 mg Coated, With Water
Hide Arm/Group Description:
Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
Overall Number of Participants Analyzed 42 42 42
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
1467.00  (560.99) 1458.45  (602.73) 1493.53  (615.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test 1: 100 mg Chewable, Without Water, Reference: 100 mg Coated, With Water
Comments Ratio between geometric means of Test 1 study treatment (chewable without water) and reference study treatment (coated with water).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Percent of reference to detect for 2-1 tests and power = 20.0%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio between geometric means
Estimated Value 98.68
Confidence Interval (2-Sided) 90%
92.03 to 105.82
Estimation Comments Estimated value = ratio (% reference).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Test 2: 100 mg Chewable, With Water, Reference: 100 mg Coated, With Water
Comments Ratio between geometric means of Test 2 study treatment (chewable with water) and reference study treatment (coated with water).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Percent of reference to detect for 2-1 tests and power = 20.0%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio between geometric means
Estimated Value 97.23
Confidence Interval (2-Sided) 90%
90.67 to 104.26
Estimation Comments Estimated value = ratio (% reference).
2.Primary Outcome
Title Maximum Plasma Concentration (Cmax)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.
Arm/Group Title Test 1: 100 mg Chewable, Without Water Test 2: 100 mg Chewable, With Water Reference: 100 mg Coated, With Water
Hide Arm/Group Description:
Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
Overall Number of Participants Analyzed 42 42 42
Mean (Standard Deviation)
Unit of Measure: ng/mL
439.38  (198.25) 434.38  (211.53) 532.31  (217.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test 1: 100 mg Chewable, Without Water, Reference: 100 mg Coated, With Water
Comments Ratio between geometric means of Test 1 study treatment (chewable without water) and reference study treatment (coated with water).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Percent of reference to detect for 2-1 tests and power = 20%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio between geometric means
Estimated Value 80.83
Confidence Interval (2-Sided) 90%
72.38 to 90.26
Estimation Comments Estimated value = ratio (% reference).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Test 2: 100 mg Chewable, With Water, Reference: 100 mg Coated, With Water
Comments Ratio between geometric means of Test 2 study treatment (chewable with water) and reference study treatment (coated with water).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Percent of reference to detect for 2-1 tests and power = 20%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio between geometric means
Estimated Value 78.76
Confidence Interval (2-Sided) 90%
70.53 to 87.96
Estimation Comments Estimated value = ratio (% reference).
3.Secondary Outcome
Title Area Under the Curve From 0 to Infinity (AUC 0-inf )
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.
Arm/Group Title Test 1: 100 mg Chewable, Without Water Test 2: 100 mg Chewable, With Water Reference: 100 mg Coated, With Water
Hide Arm/Group Description:
Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
Overall Number of Participants Analyzed 42 42 42
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
1547.92  (588.48) 1534.66  (618.86) 1573.81  (648.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test 1: 100 mg Chewable, Without Water, Reference: 100 mg Coated, With Water
Comments Ratio between geometric means of Test 1 study treatment (chewable without water) and reference study treatment (coated with water).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Percent of reference to detect for 2-1 tests and power = 20.0%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio between geometric means
Estimated Value 99.12
Confidence Interval (2-Sided) 90%
92.76 to 105.93
Estimation Comments Estimated value = ratio (% reference).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Test 2: 100 mg Chewable, With Water, Reference: 100 mg Coated, With Water
Comments Ratio between geometric means of Test 2 study treatment (chewable with water) and reference study treatment (coated with water).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Percent of reference to detect for 2-1 tests and power = 20.0%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio between geometric means
Estimated Value 97.84
Confidence Interval (2-Sided) 90%
91.56 to 104.56
Estimation Comments Estimated value = ratio (% reference).
4.Secondary Outcome
Title Time to Maximum Plasma Concentration (Tmax)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.
Arm/Group Title Test 1: 100 mg Chewable, Without Water Test 2: 100 mg Chewable, With Water Reference: 100 mg Coated, With Water
Hide Arm/Group Description:
Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
Overall Number of Participants Analyzed 42 42 42
Mean (Standard Deviation)
Unit of Measure: hours
1.46  (0.81) 1.29  (0.71) 1.28  (0.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test 1: 100 mg Chewable, Without Water, Reference: 100 mg Coated, With Water
Comments Difference in Tmax between Test 1 study treatment (chewable without water) and reference study treatment (coated with water).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.18
Confidence Interval (2-Sided) 90%
-0.14 to 0.50
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Test 2: 100 mg Chewable, With Water, Reference: 100 mg Coated, With Water
Comments Difference in Tmax between Test 2 study treatment (chewable with water) and reference study treatment (coated with water).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.01
Confidence Interval (2-Sided) 90%
-0.27 to 0.28
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Half-life (T 1/2)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.
Arm/Group Title Test 1: 100 mg Chewable, Without Water Test 2: 100 mg Chewable, With Water Reference: 100 mg Coated, With Water
Hide Arm/Group Description:
Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
Overall Number of Participants Analyzed 42 42 42
Mean (Standard Deviation)
Unit of Measure: hours
2.96  (0.63) 2.84  (0.74) 2.93  (0.81)
6.Secondary Outcome
Title Number of Participants With Clinically Significant Findings in Vital Signs
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Test 1: 100 mg Chewable, Without Water Test 2: 100 mg Chewable, With Water Reference: 100 mg Coated, With Water
Hide Arm/Group Description:
Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
Overall Number of Participants Analyzed 47 47 47
Measure Type: Number
Unit of Measure: participants
0 1 0
Time Frame [Not Specified]
Adverse Event Reporting Description 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.
 
Arm/Group Title Test 1: 100 mg Chewable, Without Water Test 2: 100 mg Chewable, With Water Reference: 100 mg Coated, With Water Formulation Unspecified
Hide Arm/Group Description Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water Sildenafil 100 mg tablet: formulation unspecified
All-Cause Mortality
Test 1: 100 mg Chewable, Without Water Test 2: 100 mg Chewable, With Water Reference: 100 mg Coated, With Water Formulation Unspecified
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Test 1: 100 mg Chewable, Without Water Test 2: 100 mg Chewable, With Water Reference: 100 mg Coated, With Water Formulation Unspecified
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)   0/47 (0.00%)   0/47 (0.00%)   0/47 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Test 1: 100 mg Chewable, Without Water Test 2: 100 mg Chewable, With Water Reference: 100 mg Coated, With Water Formulation Unspecified
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/47 (6.38%)   3/47 (6.38%)   3/47 (6.38%)   18/47 (38.30%) 
General disorders         
Headache  1  3/47 (6.38%)  2/47 (4.26%)  2/47 (4.26%)  0/47 (0.00%) 
Nausea  1  1/47 (2.13%)  0/47 (0.00%)  1/47 (2.13%)  0/47 (0.00%) 
Loose stools  1  1/47 (2.13%)  0/47 (0.00%)  0/47 (0.00%)  0/47 (0.00%) 
Hypotension  1  0/47 (0.00%)  1/47 (2.13%)  0/47 (0.00%)  0/47 (0.00%) 
Vomiting  1  0/47 (0.00%)  0/47 (0.00%)  1/47 (2.13%)  0/47 (0.00%) 
Laboratory change: urine  1  0/47 (0.00%)  0/47 (0.00%)  0/47 (0.00%)  8/47 (17.02%) 
Laboratory change: red blood cell count  1  0/47 (0.00%)  0/47 (0.00%)  0/47 (0.00%)  4/47 (8.51%) 
Laboratory change: triglycerides  1  0/47 (0.00%)  0/47 (0.00%)  0/47 (0.00%)  2/47 (4.26%) 
Laboratory change: glucose  1  0/47 (0.00%)  0/47 (0.00%)  0/47 (0.00%)  3/47 (6.38%) 
Laboratory change: cholesterol  1  0/47 (0.00%)  0/47 (0.00%)  0/47 (0.00%)  2/47 (4.26%) 
Laboratory change: white blood cells  1  0/47 (0.00%)  0/47 (0.00%)  0/47 (0.00%)  1/47 (2.13%) 
Laboratory changes unspecified  1  0/47 (0.00%)  0/47 (0.00%)  0/47 (0.00%)  2/47 (4.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, Verbatim term
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00904748     History of Changes
Other Study ID Numbers: A1481272
JPJ 39/09
First Submitted: May 19, 2009
First Posted: May 20, 2009
Results First Submitted: March 7, 2011
Results First Posted: April 4, 2011
Last Update Posted: May 20, 2011