Trial Outcomes & Findings for A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate (NCT NCT00904748)
NCT ID: NCT00904748
Last Updated: 2021-02-01
Results Overview
Area under the blood concentration-time profile from time zero to last experimentally determined concentration measured in nanograms\*hour/milliliter (ng\*hr/mL).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
47 participants
Primary outcome timeframe
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
Results posted on
2021-02-01
Participant Flow
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.
Participant milestones
| Measure |
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)
|
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)
|
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)
|
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
|
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)
|
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
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
Received Treatment
|
8
|
8
|
8
|
8
|
7
|
8
|
|
Overall Study
COMPLETED
|
7
|
7
|
7
|
6
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
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)
|
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)
|
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)
|
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
|
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)
|
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
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
2
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=48 Participants
Includes all participants who were randomized to any treatment sequence
|
|---|---|
|
Age, Continuous
|
29.3 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 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-dosePopulation: Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.
Area under the blood concentration-time profile from time zero to last experimentally determined concentration measured in nanograms\*hour/milliliter (ng\*hr/mL).
Outcome measures
| Measure |
Test 1: 100 mg Chewable, Without Water
n=42 Participants
Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
|
Test 2: 100 mg Chewable, With Water
n=42 Participants
Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
|
Reference: 100 mg Coated, With Water
n=42 Participants
Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
|
|---|---|---|---|
|
Area Under the Curve (AUC 0-t)
|
1467.00 ng*hr/mL
Standard Deviation 560.99
|
1458.45 ng*hr/mL
Standard Deviation 602.73
|
1493.53 ng*hr/mL
Standard Deviation 615.59
|
PRIMARY outcome
Timeframe: 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-dosePopulation: Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.
Maximum plasma concentration measured in nanograms per milliliter (ng/mL).
Outcome measures
| Measure |
Test 1: 100 mg Chewable, Without Water
n=42 Participants
Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
|
Test 2: 100 mg Chewable, With Water
n=42 Participants
Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
|
Reference: 100 mg Coated, With Water
n=42 Participants
Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
439.38 ng/mL
Standard Deviation 198.25
|
434.38 ng/mL
Standard Deviation 211.53
|
532.31 ng/mL
Standard Deviation 217.32
|
SECONDARY outcome
Timeframe: 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-dosePopulation: Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.
Area under the blood concentration-time profile from time zero extrapolated to infinite time measured in nanograms \*hour/milliliter (ng\*hr/mL).
Outcome measures
| Measure |
Test 1: 100 mg Chewable, Without Water
n=42 Participants
Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
|
Test 2: 100 mg Chewable, With Water
n=42 Participants
Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
|
Reference: 100 mg Coated, With Water
n=42 Participants
Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
|
|---|---|---|---|
|
Area Under the Curve From 0 to Infinity (AUC 0-inf )
|
1547.92 ng*hr/mL
Standard Deviation 588.48
|
1534.66 ng*hr/mL
Standard Deviation 618.86
|
1573.81 ng*hr/mL
Standard Deviation 648.32
|
SECONDARY outcome
Timeframe: 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-dosePopulation: Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.
Time at which maximum plasma concentration (Cmax) occurred.
Outcome measures
| Measure |
Test 1: 100 mg Chewable, Without Water
n=42 Participants
Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
|
Test 2: 100 mg Chewable, With Water
n=42 Participants
Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
|
Reference: 100 mg Coated, With Water
n=42 Participants
Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
|
|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax)
|
1.46 hours
Standard Deviation 0.81
|
1.29 hours
Standard Deviation 0.71
|
1.28 hours
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: 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-dosePopulation: Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.
Terminal elimination half-life.
Outcome measures
| Measure |
Test 1: 100 mg Chewable, Without Water
n=42 Participants
Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
|
Test 2: 100 mg Chewable, With Water
n=42 Participants
Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
|
Reference: 100 mg Coated, With Water
n=42 Participants
Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
|
|---|---|---|---|
|
Half-life (T 1/2)
|
2.96 hours
Standard Deviation 0.63
|
2.84 hours
Standard Deviation 0.74
|
2.93 hours
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
Test 1: 100 mg Chewable, Without Water
n=47 Participants
Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
|
Test 2: 100 mg Chewable, With Water
n=47 Participants
Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
|
Reference: 100 mg Coated, With Water
n=47 Participants
Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Findings in Vital Signs
|
0 participants
|
1 participants
|
0 participants
|
Adverse Events
Test 1: 100 mg Chewable, Without Water
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Test 2: 100 mg Chewable, With Water
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Reference: 100 mg Coated, With Water
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Formulation Unspecified
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test 1: 100 mg Chewable, Without Water
n=47 participants at risk
Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
|
Test 2: 100 mg Chewable, With Water
n=47 participants at risk
Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
|
Reference: 100 mg Coated, With Water
n=47 participants at risk
Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
|
Formulation Unspecified
n=47 participants at risk
Sildenafil 100 mg tablet: formulation unspecified
|
|---|---|---|---|---|
|
General disorders
Headache
|
6.4%
3/47
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.
|
4.3%
2/47
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.
|
4.3%
2/47
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.
|
0.00%
0/47
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.
|
|
General disorders
Nausea
|
2.1%
1/47
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.
|
0.00%
0/47
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.
|
2.1%
1/47
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.
|
0.00%
0/47
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.
|
|
General disorders
Loose stools
|
2.1%
1/47
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.
|
0.00%
0/47
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.
|
0.00%
0/47
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.
|
0.00%
0/47
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.
|
|
General disorders
Hypotension
|
0.00%
0/47
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.
|
2.1%
1/47
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.
|
0.00%
0/47
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.
|
0.00%
0/47
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.
|
|
General disorders
Vomiting
|
0.00%
0/47
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.
|
0.00%
0/47
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.
|
2.1%
1/47
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.
|
0.00%
0/47
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.
|
|
General disorders
Laboratory change: urine
|
0.00%
0/47
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.
|
0.00%
0/47
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.
|
0.00%
0/47
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.
|
17.0%
8/47
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.
|
|
General disorders
Laboratory change: red blood cell count
|
0.00%
0/47
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.
|
0.00%
0/47
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.
|
0.00%
0/47
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.
|
8.5%
4/47
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.
|
|
General disorders
Laboratory change: triglycerides
|
0.00%
0/47
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.
|
0.00%
0/47
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.
|
0.00%
0/47
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.
|
4.3%
2/47
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.
|
|
General disorders
Laboratory change: glucose
|
0.00%
0/47
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.
|
0.00%
0/47
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.
|
0.00%
0/47
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.
|
6.4%
3/47
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.
|
|
General disorders
Laboratory change: cholesterol
|
0.00%
0/47
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.
|
0.00%
0/47
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.
|
0.00%
0/47
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.
|
4.3%
2/47
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.
|
|
General disorders
Laboratory change: white blood cells
|
0.00%
0/47
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.
|
0.00%
0/47
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.
|
0.00%
0/47
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.
|
2.1%
1/47
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.
|
|
General disorders
Laboratory changes unspecified
|
0.00%
0/47
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.
|
0.00%
0/47
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.
|
0.00%
0/47
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.
|
4.3%
2/47
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER