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A Pivotal Bioequivalence Study Between The Sildenafil Powder For Oral Suspension (10 Mg/Ml) And The Sildenafil 10 Mg Immediate Release (IR) Tablet Relative To The Revatio 20 Mg IR Tablet In Healthy Volunteers Under Fasting Conditions

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bruxelles, , B-1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Arterial Hypertention
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1) Healthy male/female subjects between the ages of 18 and 55 years, inclusive. Healthy is
defined as no clinically relevant abnormalities identified by a detailed medical history,
full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG
and clinical laboratory tests.

2. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

3. An informed consent document signed and dated by the subject or a legally acceptable
representative.

4. Subjects who are willing and able to comply with all scheduled visits, treatment plan,
laboratory tests, and other study procedures.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, ocular
or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal
allergies at the time of dosing) disease or clinical findings at Screening.

2. History of febrile illness within 5 days prior to the first dose.

3. A positive urine drug screen.

NCT01247805
Pfizer
Completed
A Pivotal Bioequivalence Study Between The Sildenafil Powder For Oral Suspension (10 Mg/Ml) And The Sildenafil 10 Mg Immediate Release (IR) Tablet Relative To The Revatio 20 Mg IR Tablet In Healthy Volunteers Under Fasting Conditions

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A Pivotal Bioequivalence Study Between The Sildenafil Powder For Oral Suspension (10 Mg/Ml) And The Sildenafil 10 Mg Immediate Release (IR) Tablet Relative To The Revatio 20 Mg IR Tablet In Healthy Volunteers Under Fasting Conditions
A Pivotal Randomised, Open-Label 3-Way Crossover Study To Demonstrate Bioequivalence Of The Sildenafil Citrate Powder For Oral Suspension (10 Mg/Ml) And The Sildenafil Citrate 10 Mg Immediate Release (IR) Tablet Relative To The Revatio 20 Mg IR Tablet In Healthy Volunteers Under Fasting Conditions
The hypothesis for the trial is that the Sildenafil Citrate Powder for Oral Suspension (10 Mg/ml) bioequivalent to the Revatio 20 Mg IR tablet in Healthy Volunteers and the Sildenafil Citrate 10 Mg immediate release (IR) tablet is bioequivalent to the Revatio 20 Mg IR tablet in Healthy Volunteers.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pulmonary Arterial Hypertention
  • Drug: sildenafil citrate
    Single oral dose of 1 x 20 mg IR oral tablet.
    Other Name: Revatio
  • Drug: Sildenafil citrate
    single oral dose of 2 x 10 mg sildenafil citrate IR oral tablet.
    Other Name: Revatio
  • Drug: sildenafil citrate
    single oral dose of 2 mL of the 10 mg/mL sildenafil citrate POS (20 mg dose).
    Other Name: Revatio
  • Experimental: Treatment A
    Revatio: 1 x 20 mg IR oral tablet.
    Intervention: Drug: sildenafil citrate
  • Experimental: Treatment B
    2 x 10 mg sildenafil citrate IR oral tablet.
    Intervention: Drug: Sildenafil citrate
  • Experimental: Treatment C
    2 mL of the 10 mg/mL sildenafil citrate POS (20 mg dose).
    Intervention: Drug: sildenafil citrate
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
February 2011
February 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

1) Healthy male/female subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.

2. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

3. An informed consent document signed and dated by the subject or a legally acceptable representative.

4. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, ocular or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) disease or clinical findings at Screening.
  2. History of febrile illness within 5 days prior to the first dose.
  3. A positive urine drug screen.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01247805
A1481293
EudraCT 2010-023521-38
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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