A Relative Bioavailability Study of Revatio for the Crushed Tablets, Extemporaneously Prepared Formulation, and the Intact Tablets at 20 mg Dose in Healthy Volunteers
Primary Purpose
Healthy
Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
Revatio
Revatio
Revatio
Sponsored by
About this trial
This is an interventional other trial for Healthy focused on measuring Bioavailability, Revatio, Healthy Volunteers
Eligibility Criteria
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.
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Treatment A
Treatment B
Treatment C
Arm Description
Revatio 20 mg intact tablet. This is the reference treatment arm.
Treatment B: Revatio 20 mg crushed tablet mixed with apple sauce.
Treatment C: Revatio 20 mg extemporaneously prepared suspension (EP).
Outcomes
Primary Outcome Measures
AUClast
Cmax
Secondary Outcome Measures
T1/2
AUCinf
Tmax
Full Information
NCT ID
NCT01027117
First Posted
September 29, 2009
Last Updated
January 28, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01027117
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Bioavailability, Revatio, Healthy Volunteers
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment A
Arm Type
Active Comparator
Arm Description
Revatio 20 mg intact tablet. This is the reference treatment arm.
Arm Title
Treatment B
Arm Type
Experimental
Arm Description
Treatment B: Revatio 20 mg crushed tablet mixed with apple sauce.
Arm Title
Treatment C
Arm Type
Experimental
Arm Description
Treatment C: Revatio 20 mg extemporaneously prepared suspension (EP).
Intervention Type
Drug
Intervention Name(s)
Revatio
Intervention Description
Three treatments as described in study design, single dose, three way crossover. The treatment duration will be minimum 3 days for each subject.
Intervention Type
Drug
Intervention Name(s)
Revatio
Intervention Description
Three treatments as described in study design, single dose, three way crossover. The treatment duration will be minimum 3 days for each subject.
Intervention Type
Drug
Intervention Name(s)
Revatio
Intervention Description
Three treatments as described in study design, single dose, three way crossover. The treatment duration will be minimum 3 days for each subject.
Primary Outcome Measure Information:
Title
AUClast
Time Frame
Within 14 hours post dose
Title
Cmax
Time Frame
Within 14 hours post dose
Secondary Outcome Measure Information:
Title
T1/2
Time Frame
Within 14 hours post dose
Title
AUCinf
Time Frame
Within 14 hours post dose
Title
Tmax
Time Frame
Within 14 hours post dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
A Relative Bioavailability Study of Revatio for the Crushed Tablets, Extemporaneously Prepared Formulation, and the Intact Tablets at 20 mg Dose in Healthy Volunteers
We'll reach out to this number within 24 hrs