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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

About this trial

This is an interventional other trial for Healthy focused on measuring Bioavailability, Revatio, Healthy Volunteers

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

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

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

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

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