A1481272: A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00904748
• Collaborator: (none)
• Enrollment: 47
• Location: 1
• Arms: 3
• Duration (Months): 1.9
• Patients Per Site Per Month: 24.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: sildenafil citrate 100 mg CT; Drug: sildenafil citrate 100 mg CT; Drug: Viagra®	Phase 1

Detailed Description

Bio-equivalence between two formulations of sildenafil citrate

Study Design

• Study Type: Interventional
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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.
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test 1	Drug: sildenafil citrate 100 mg CT; sildenafil citrate 100 mg CT, single dose without water
Experimental: Test 2	Drug: sildenafil citrate 100 mg CT; sildenafil citrate 100 mg CT, single dose with water
Active Comparator: Reference	Drug: Viagra®; sildenafil citrate 100 mg film-coated tablet (Viagra®), single dose

Outcome Measures

Primary Outcome Measures

1. Area Under the Curve (AUC 0-t) [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).

2. Maximum Plasma Concentration (Cmax) [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).

Secondary Outcome Measures

1. Area Under the Curve From 0 to Infinity (AUC 0-inf ) [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 extrapolated to infinite time measured in nanograms *hour/milliliter (ng*hr/mL).

2. Time to Maximum Plasma Concentration (Tmax) [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 at which maximum plasma concentration (Cmax) occurred.

3. Half-life (T 1/2) [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]

   Terminal elimination half-life.

4. Number of Participants With Clinically Significant Findings in Vital Signs [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.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: 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:

• 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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Braganca Paulista	SP	Brazil	12916-900

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00904748
• Other Study ID Numbers: A1481272; JPJ 39/09
• First Posted: May 20, 2009
• Last Update Posted: Feb 1, 2021
• Last Verified: Jan 1, 2021

• Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: Sildenafil; Bio-equivalence
• Additional relevant MeSH terms: Erectile Dysfunction; Sildenafil Citrate; Citric Acid; Sodium Citrate

Study Results

Participant Flow

Pre-assignment Detail	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
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	8
Received Treatment	8	8	8	8	7	8
COMPLETED	7	7	7	6	7	8
NOT COMPLETED	1	1	1	2	1	0

Baseline Characteristics

Arm/Group Title	Entire Study Population
Arm/Group Description	Includes all participants who were randomized to any treatment sequence
Overall Participants	48
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	29.3
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	48 100%

Outcome Measures

1. Primary Outcome

Title	Area Under the Curve (AUC 0-t)
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

Outcome Measure Data

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
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
Measure Participants	42	42	42
Mean (Standard Deviation) [ng*hr/mL]	1467.00 (560.99)	1458.45 (602.73)	1493.53 (615.59)

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 (legacy)
	Comments	Percent of reference to detect for 2-1 tests and power = 20.0%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	ratio between geometric means
	Estimated Value	98.68
	Confidence Interval	(2-Sided) 90%; 92.03 to 105.82
	Parameter Dispersion	Type: Value:
	Estimation Comments	Estimated value = ratio (% reference).

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 (legacy)
	Comments	Percent of reference to detect for 2-1 tests and power = 20.0%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	ratio between geometric means
	Estimated Value	97.23
	Confidence Interval	(2-Sided) 90%; 90.67 to 104.26
	Parameter Dispersion	Type: Value:
	Estimation Comments	Estimated value = ratio (% reference).

2. Primary Outcome

Title	Maximum Plasma Concentration (Cmax)
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

Outcome Measure Data

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
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
Measure Participants	42	42	42
Mean (Standard Deviation) [ng/mL]	439.38 (198.25)	434.38 (211.53)	532.31 (217.32)

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 (legacy)
	Comments	Percent of reference to detect for 2-1 tests and power = 20%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	ratio between geometric means
	Estimated Value	80.83
	Confidence Interval	(2-Sided) 90%; 72.38 to 90.26
	Parameter Dispersion	Type: Value:
	Estimation Comments	Estimated value = ratio (% reference).

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 (legacy)
	Comments	Percent of reference to detect for 2-1 tests and power = 20%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	ratio between geometric means
	Estimated Value	78.76
	Confidence Interval	(2-Sided) 90%; 70.53 to 87.96
	Parameter Dispersion	Type: Value:
	Estimation Comments	Estimated value = ratio (% reference).

3. Secondary Outcome

Title	Area Under the Curve From 0 to Infinity (AUC 0-inf )
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

Outcome Measure Data

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
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
Measure Participants	42	42	42
Mean (Standard Deviation) [ng*hr/mL]	1547.92 (588.48)	1534.66 (618.86)	1573.81 (648.32)

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 (legacy)
	Comments	Percent of reference to detect for 2-1 tests and power = 20.0%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	ratio between geometric means
	Estimated Value	99.12
	Confidence Interval	(2-Sided) 90%; 92.76 to 105.93
	Parameter Dispersion	Type: Value:
	Estimation Comments	Estimated value = ratio (% reference).

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 (legacy)
	Comments	Percent of reference to detect for 2-1 tests and power = 20.0%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	ratio between geometric means
	Estimated Value	97.84
	Confidence Interval	(2-Sided) 90%; 91.56 to 104.56
	Parameter Dispersion	Type: Value:
	Estimation Comments	Estimated value = ratio (% reference).

4. Secondary Outcome

Title	Time to Maximum Plasma Concentration (Tmax)
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

Outcome Measure Data

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
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
Measure Participants	42	42	42
Mean (Standard Deviation) [hours]	1.46 (0.81)	1.29 (0.71)	1.28 (0.85)

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 (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.18
	Confidence Interval	(2-Sided) 90%; -0.14 to 0.50
	Parameter Dispersion	Type: Value:
	Estimation Comments

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 (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.01
	Confidence Interval	(2-Sided) 90%; -0.27 to 0.28
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Half-life (T 1/2)
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

Outcome Measure Data

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
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
Measure Participants	42	42	42
Mean (Standard Deviation) [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
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.

Outcome Measure Data

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
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
Measure Participants	47	47	47
Number [participants]	0 0%	1 NaN	0 NaN

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/47 (0%)		0/47 (0%)		0/47 (0%)		0/47 (0%)
Other (Not Including 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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/47 (6.4%)		3/47 (6.4%)		3/47 (6.4%)		18/47 (38.3%)
General disorders
Headache	3/47 (6.4%)		2/47 (4.3%)		2/47 (4.3%)		0/47 (0%)
Nausea	1/47 (2.1%)		0/47 (0%)		1/47 (2.1%)		0/47 (0%)
Loose stools	1/47 (2.1%)		0/47 (0%)		0/47 (0%)		0/47 (0%)
Hypotension	0/47 (0%)		1/47 (2.1%)		0/47 (0%)		0/47 (0%)
Vomiting	0/47 (0%)		0/47 (0%)		1/47 (2.1%)		0/47 (0%)
Laboratory change: urine	0/47 (0%)		0/47 (0%)		0/47 (0%)		8/47 (17%)
Laboratory change: red blood cell count	0/47 (0%)		0/47 (0%)		0/47 (0%)		4/47 (8.5%)
Laboratory change: triglycerides	0/47 (0%)		0/47 (0%)		0/47 (0%)		2/47 (4.3%)
Laboratory change: glucose	0/47 (0%)		0/47 (0%)		0/47 (0%)		3/47 (6.4%)
Laboratory change: cholesterol	0/47 (0%)		0/47 (0%)		0/47 (0%)		2/47 (4.3%)
Laboratory change: white blood cells	0/47 (0%)		0/47 (0%)		0/47 (0%)		1/47 (2.1%)
Laboratory changes unspecified	0/47 (0%)		0/47 (0%)		0/47 (0%)		2/47 (4.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.