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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

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ClinicalTrials.gov Identifier: NCT01247805
Recruitment Status : Completed
First Posted : November 24, 2010
Last Update Posted : February 11, 2011
Sponsor:
Information provided by:
Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertention Drug: sildenafil citrate Drug: Sildenafil citrate Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2011
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment A
Revatio: 1 x 20 mg IR oral tablet.
Drug: sildenafil citrate
Single oral dose of 1 x 20 mg IR oral tablet.
Other Name: Revatio

Experimental: Treatment B
2 x 10 mg sildenafil citrate IR oral tablet.
Drug: Sildenafil citrate
single oral dose of 2 x 10 mg sildenafil citrate IR oral tablet.
Other Name: Revatio

Experimental: Treatment C
2 mL of the 10 mg/mL sildenafil citrate POS (20 mg dose).
Drug: sildenafil citrate
single oral dose of 2 mL of the 10 mg/mL sildenafil citrate POS (20 mg dose).
Other Name: Revatio




Primary Outcome Measures :
  1. Area under the curve (AUC0-T) of sildenafil plasma concentrations from time zero to the time T of last measurable concentration. [ Time Frame: Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose ]
  2. Maximum sildenafil plasma concentration (Cmax) [ Time Frame: Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose ]

Secondary Outcome Measures :
  1. AUCinf, AUC of sildenafil from time zero to time infinity. AUCinf = AUC0-T+AUCextrapolated [ Time Frame: Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose ]
  2. AUC%extrapolated of sildenafil. [ Time Frame: Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose ]
  3. Tmax - time at which maximum sildenafil plasma concentration occurs [ Time Frame: Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose ]
  4. Adverse events [ Time Frame: From FSFV to LSLV, up to 5 weeks ]
  5. terminal half-life of sildenafil. [ Time Frame: Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247805


Locations
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Belgium
Pfizer Investigational Site
Bruxelles, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01247805    
Other Study ID Numbers: A1481293
EudraCT 2010-023521-38
First Posted: November 24, 2010    Key Record Dates
Last Update Posted: February 11, 2011
Last Verified: February 2011
Keywords provided by Pfizer:
Bioequivalence
Powder for oral suspention
Additional relevant MeSH terms:
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Sildenafil Citrate
Citric Acid
Sodium Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents