A Relative Bioavailability Study of Revatio for the Crushed Tablets, Extemporaneously Prepared Formulation, and the Intact Tablets at 20 mg Dose in Healthy Volunteers

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NCT01027117

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Study Location
Pfizer Investigational Site
Bruxelles, , 1070, Belgium
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
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

- 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.

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

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

- Subjects who are willing and able to comply with 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


- 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 time of dosing) disease or clinical findings at Screening.


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


- Any condition possibly affecting drug absorption (eg, gastrectomy).


- A positive urine drug screen.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Relative Bioavailability Study of Revatio for the Crushed Tablets, Extemporaneously Prepared Formulation, and the Intact Tablets at 20 mg Dose in Healthy Volunteers
Official Title  ICMJE A Randomised, Open-Label 3-Way Crossover Study To Investigate The Relative Bioavailability Of The Crushed Revatio 20 Mg Tablet Mixed With Apple Sauce, The Extemporaneously Prepared Suspension (EP), And The Intact Revatio 20 Mg Tablet In Healthy Volunteers Under Fasting Conditions
Brief Summary

This will be a randomized, open-label, 3-treatment, 3-period, crossover, single-dose study in healthy subjects. Eighteen (18) subjects will complete the study; dropouts may be replaced at the discretion of the sponsor. Three treatments are:

Treatment A: Revatio 20 mg intact tablet. Treatment B: Revatio 20 mg crushed tablet mixed with apple sauce. Treatment C: Revatio 20 mg extemporaneously prepared suspension (EP). Blood samples for the analysis of sildenafil in plasma will be obtained pre-dose and up to 14 hours post dose in each period. Tolerability and safety will be assessed by reported adverse events during each study period.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE Drug: Revatio
Three treatments as described in study design, single dose, three way crossover. The treatment duration will be minimum 3 days for each subject.
Study Arms  ICMJE
  • Active Comparator: Treatment A
    Revatio 20 mg intact tablet. This is the reference treatment arm.
    Intervention: Drug: Revatio
  • Experimental: Treatment B
    Treatment B: Revatio 20 mg crushed tablet mixed with apple sauce.
    Intervention: Drug: Revatio
  • Experimental: Treatment C
    Treatment C: Revatio 20 mg extemporaneously prepared suspension (EP).
    Intervention: Drug: Revatio
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2009)		18
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • An informed consent document signed and dated by the subject or a legally acceptable representative.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

  • 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 time of dosing) disease or clinical findings at Screening.
  • History of febrile illness within 5 days prior to the first dose.
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01027117
Other Study ID Numbers  ICMJE A1481275
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP